Back to resultsImmunogenicity and Safety Study in Infants of GlaxoSmithKline Biologicals' Infanrix Hexa™ (DTPa-HBV-IPV/Hib) Vaccine
Primary Purpose
Poliomyelitis, Tetanus, Acellular Pertussis
Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Infanrix hexa™
Sponsored by
About this trial
This is an interventional prevention trial for Poliomyelitis focused on measuring Infanrix hexa™, Primary vaccination, India, combination vaccine, infants
Eligibility Criteria
Inclusion Criteria:
All subjects must satisfy ALL the following criteria at study entry:
- A male or female between, and including, 6 and 10 weeks of age at the time of the first vaccination
- Documented administration of a hepatitis B vaccine dose at birth
- 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
- Born after a gestation period of at least 36 weeks
Exclusion Criteria:
The following criteria should be checked at the time of study entry. If ANYexclusion criterion applies, the subject must not be included in the study:
- Child in care
- Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose, or planned use during the study period
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose
- Administration of a vaccine not foreseen by the study protocol, within 30 days prior to the first study visit, or planned administration during the study period, with the exception of oral human rotavirus (HRV) vaccination which is allowed at any time during the study
- 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 diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b (Hib) vaccination or disease, with the exception of a birth dose of hepatitis B vaccine and oral poliovirus vaccine (OPV) as per local standard of care
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- Family history of congenital or hereditary immunodeficiency
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine
- Major congenital defects or serious chronic illness
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period
- Acute disease and/or fever at the time of enrolment
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
INFANRIX HEXA 6-10-14 GROUP
INFANRIX HEXA 2-4-6 GROUP
Arm Description
Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.
Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.
Outcomes
Primary Outcome Measures
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens
A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
Number of Seroprotected Subjects Against Hepatitis B (HBs)
A seroprotected subject was defined as a vaccinated subject with anti-HBS antibody concentration ≥ 10 milli-international units per milliliter (mIU/mL).
Number of Seroprotected Subjects Against Poliovirus (Polio) Types 1,2,3 Antigens
A seroprotected subject was defined as a subject with anti-Poliovirus 1,2 and 3 antibody titers ≥ 8 effective dose, for 50% of people receiving the vaccine (ED50).
Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP) Antigens
A seroprotected subject was defined as a subject with anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).
Number of Subjects With Vaccine Response for Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)
Vaccine response was defined as : For initially seronegative subjects (S-), antibody concentration ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) at 1 month after the third dose; For initially seropositive subjects (S+): antibody concentration at 1 month after the third dose ≥ 1 fold increase in the pre-vaccination antibody concentration.
Secondary Outcome Measures
Anti-D and Anti-T Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).
Anti-HBs Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
Anti-Polio Types 1, 2, 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.
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 Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN
A seropositive 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 Polio Type 1, 2 and 3 Antigens
A seroprotected subject was defined as a subject with anti-Polio type 1, 2 and 3 antibody titers ≥ 8 effective dose, for 50% of people receiving the vaccine (ED50).
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN
A seropositive 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 Anti-HBs Antigens
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/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.
Anti-HBs Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.
Number of Subjects With Any Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of any particular symptom regardless of intensity grade.
Number of Subjects With Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = incidence of any particular 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
NCT01353703
Brief Title
Immunogenicity and Safety Study in Infants of GlaxoSmithKline Biologicals' Infanrix Hexa™ (DTPa-HBV-IPV/Hib) Vaccine
Official Title
Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Infanrix Hexa™ Vaccine in Healthy Infants in India
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
April 16, 2012 (Actual)
Primary Completion Date
February 25, 2013 (Actual)
Study Completion Date
February 25, 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 evaluates the immunogenicity and safety of Infanrix hexa™ (DTPa-HBV-IPV/Hib) when administered as a primary vaccination course to Indian infants according to a 6-10-14 weeks or a 2-4-6 months schedule.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Poliomyelitis, Tetanus, Acellular Pertussis, Haemophilus Influenzae Type b, Diphtheria, Hepatitis B, Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b Vaccines
Keywords
Infanrix hexa™, Primary vaccination, India, combination vaccine, infants
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
224 (Actual)
8. Arms, Groups, and Interventions
Arm Title
INFANRIX HEXA 6-10-14 GROUP
Arm Type
Experimental
Arm Description
Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.
Arm Title
INFANRIX HEXA 2-4-6 GROUP
Arm Type
Active Comparator
Arm Description
Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.
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 Diphteria (D) and Tetanus (T) Antigens
Description
A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
Time Frame
One month post Dose 3 (Month 3 or Month 5)
Title
Number of Seroprotected Subjects Against Hepatitis B (HBs)
Description
A seroprotected subject was defined as a vaccinated subject with anti-HBS antibody concentration ≥ 10 milli-international units per milliliter (mIU/mL).
Time Frame
One month post Dose 3 (Month 3 or Month 5)
Title
Number of Seroprotected Subjects Against Poliovirus (Polio) Types 1,2,3 Antigens
Description
A seroprotected subject was defined as a subject with anti-Poliovirus 1,2 and 3 antibody titers ≥ 8 effective dose, for 50% of people receiving the vaccine (ED50).
Time Frame
One month post Dose 3 (Month 3 or Month 5)
Title
Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP) Antigens
Description
A seroprotected subject was defined as a subject with anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).
Time Frame
One month post Dose 3 (Month 3 or Month 5)
Title
Number of Subjects With Vaccine Response for Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)
Description
Vaccine response was defined as : For initially seronegative subjects (S-), antibody concentration ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) at 1 month after the third dose; For initially seropositive subjects (S+): antibody concentration at 1 month after the third dose ≥ 1 fold increase in the pre-vaccination antibody concentration.
Time Frame
One month post Dose 3 (Month 3 or Month 5)
Secondary Outcome Measure Information:
Title
Anti-D and Anti-T Antibody Concentrations
Description
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).
Time Frame
One month post Dose 3 (Month 3 or Month 5)
Title
Anti-HBs Antibody Concentrations
Description
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
Time Frame
One month post Dose 3 (Month 3 or Month 5)
Title
Anti-Polio Types 1, 2, 3 Antibody Titers
Description
Antibody titers were presented as geometric mean titers (GMTs).
Time Frame
One month post Dose 3 (Month 3 or Month 5)
Title
Anti-PRP Antibody Concentrations
Description
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.
Time Frame
One month post Dose 3 (Month 3 or Month 5)
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 post Dose 3 (Month 3 or Month 5)
Title
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN
Description
A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.
Time Frame
One month post Dose 3 (Month 3 or Month 5)
Title
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens
Description
A seroprotected subject was defined as a subject with anti-Polio type 1, 2 and 3 antibody titers ≥ 8 effective dose, for 50% of people receiving the vaccine (ED50).
Time Frame
At Month 0
Title
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN
Description
A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.
Time Frame
At Month 0
Title
Number of Seroprotected Subjects Against Anti-HBs Antigens
Description
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.
Time Frame
At Month 0
Title
Anti-Polio Types 1, 2 and 3 Antibody Titers
Description
Antibody titers were presented as geometric mean titers (GMTs).
Time Frame
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
At Month 0
Title
Anti-HBs Antibody Concentrations
Description
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.
Time Frame
At Month 0
Title
Number of Subjects With Any Solicited Local Symptoms
Description
Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of any particular symptom regardless of intensity grade.
Time Frame
During the 4-day (Days 0-3) post-vaccination period after each dose and across doses: Up to Month 2 (Infanrix Hexa 6-10-14 Group) or Month 4 (Infanrix Hexa 2-4-6 Group)
Title
Number of Subjects With Solicited General Symptoms
Description
Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = incidence of any particular symptom regardless of intensity grade or relationship to study vaccination.
Time Frame
During the 4-day (Days 0-3) post-vaccination period after each dose and across doses: Up to Month 2 (Infanrix Hexa 6-10-14 Group) or Month 4 (Infanrix Hexa 2-4-6 Group)
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: Up to Month 3 (Infanrix Hexa 6-10-14 Group) or Month 5 (Infanrix Hexa 2-4-6 Group)
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 3 (Infanrix Hexa 6-10-14 Group) or Month 5 (Infanrix Hexa 2-4-6 Group))
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
10 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All subjects must satisfy ALL the following criteria at study entry:
A male or female between, and including, 6 and 10 weeks of age at the time of the first vaccination
Documented administration of a hepatitis B vaccine dose at birth
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
Born after a gestation period of at least 36 weeks
Exclusion Criteria:
The following criteria should be checked at the time of study entry. If ANYexclusion criterion applies, the subject must not be included in the study:
Child in care
Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose, or planned use during the study period
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose
Administration of a vaccine not foreseen by the study protocol, within 30 days prior to the first study visit, or planned administration during the study period, with the exception of oral human rotavirus (HRV) vaccination which is allowed at any time during the study
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 diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b (Hib) vaccination or disease, with the exception of a birth dose of hepatitis B vaccine and oral poliovirus vaccine (OPV) as per local standard of care
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
Family history of congenital or hereditary immunodeficiency
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine
Major congenital defects or serious chronic illness
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period
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
Belgaun
ZIP/Postal Code
590010
Country
India
Facility Name
GSK Investigational Site
City
Chennai
Country
India
Facility Name
GSK Investigational Site
City
Pune
ZIP/Postal Code
411018
Country
India
Facility Name
GSK Investigational Site
City
Pune
Country
India
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://clinicalstudydatarequest.com/Posting.aspx?ID=4632
Citations:
PubMed Identifier
27629913
Citation
Lalwani SK, Agarkhedkar S, Sundaram B, Mahantashetti NS, Malshe N, Agarkhedkar S, Van Der Meeren O, Mehta S, Karkada N, Han HH, Mesaros N. Immunogenicity and safety of 3-dose primary vaccination with combined DTPa-HBV-IPV/Hib in Indian infants. Hum Vaccin Immunother. 2017 Jan 2;13(1):120-127. doi: 10.1080/21645515.2016.1225639. Epub 2016 Sep 15.
Results Reference
background
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
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
111157
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
111157
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
111157
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
111157
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
111157
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
111157
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 Safety Study in Infants of GlaxoSmithKline Biologicals' Infanrix Hexa™ (DTPa-HBV-IPV/Hib) Vaccine
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