Back to resultsImmunogenicity and Safety Study of GlaxoSmithKline Biologicals' Poliorix™ Vaccine
Primary Purpose
Poliomyelitis, Poliomyelitis Vaccines
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Poliorix™
Oral Poliovirus vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Poliomyelitis focused on measuring Poliorix, IPV
Eligibility Criteria
Inclusion Criteria:
- A male or female infant between, and including, 60 and 90 days of age at the time of the first vaccination.
- Born after a gestation period of 36 to 42 weeks inclusive.
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative (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:
- 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.
- 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 exception of DTP, Hib and/or hepatitis B vaccine(s).
- 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 poliomyelitis 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.
- Child in care.
The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved and if no other exclusion criteria are met:
• Current febrile illness or axillary temperature > 37.0 ºC or other moderate to severe illness within 24 hours of study vaccine administration.
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Poliorix Group
Control Group
Arm Description
Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix™ (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
Outcomes
Primary Outcome Measures
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
A seroprotected subject was defined as a vaccinated subject with anti-polio types 1, 2 and 3 titers greater than or equal to (≥) 8 effective dose 50 (ED50).
Secondary Outcome Measures
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
A seroprotected subject was defined as a vaccinated subject with anti-poliovirus types 1, 2 and 3 titers ≥ 8 ED50.
Anti-poliovirus Types 1, 2 and 3 Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs).
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. This outcome measure concerns subjects from the Poliorix Group only.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, gastrointestinal symptoms, irritability/fussiness, loss of appetite and fever [defined as axillary temperature higher than (>) 37.0°C degrees Celsius]. Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = subject did not eat at all. Grade 3 gastrointestinal symptoms = gastrointestinal symptoms that prevented normal activity. Grade 3 fever= temperature > 39°C. Related = symptom assessed by the investigator as causally related to the 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 results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01021293
Brief Title
Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Poliorix™ Vaccine
Official Title
Immunogenicity and Safety of GSK Biologicals' IPV (Poliorix™) in Infants
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
November 28, 2009 (Actual)
Primary Completion Date
July 5, 2010 (Actual)
Study Completion Date
July 5, 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 safety of Poliorix™ when administered to healthy Chinese infants at 2, 3 and 4 months of age.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Poliomyelitis, Poliomyelitis Vaccines
Keywords
Poliorix, IPV
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Poliorix Group
Arm Type
Experimental
Arm Description
Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix™ (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
Intervention Type
Biological
Intervention Name(s)
Poliorix™
Intervention Description
3 doses, intramuscular administration
Intervention Type
Biological
Intervention Name(s)
Oral Poliovirus vaccine
Intervention Description
3 doses, oral administration
Primary Outcome Measure Information:
Title
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
Description
A seroprotected subject was defined as a vaccinated subject with anti-polio types 1, 2 and 3 titers greater than or equal to (≥) 8 effective dose 50 (ED50).
Time Frame
At Month 3, one month after the third vaccine dose
Secondary Outcome Measure Information:
Title
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
Description
A seroprotected subject was defined as a vaccinated subject with anti-poliovirus types 1, 2 and 3 titers ≥ 8 ED50.
Time Frame
At Day 0, prior to the first vaccine dose
Title
Anti-poliovirus Types 1, 2 and 3 Antibody Titers
Description
Antibody titers were presented as geometric mean titers (GMTs).
Time Frame
Prior to the first vaccine dose (Day 0) and one month after the third vaccine dose (Month 3)
Title
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Description
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. This outcome measure concerns subjects from the Poliorix Group only.
Time Frame
During the 4-day (Days 0-3) post-vaccination period following each vaccine dose and across doses
Title
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Description
Assessed solicited general symptoms were drowsiness, gastrointestinal symptoms, irritability/fussiness, loss of appetite and fever [defined as axillary temperature higher than (>) 37.0°C degrees Celsius]. Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = subject did not eat at all. Grade 3 gastrointestinal symptoms = gastrointestinal symptoms that prevented normal activity. Grade 3 fever= temperature > 39°C. Related = symptom assessed by the investigator as causally related to the vaccination.
Time Frame
During the 4-day (Days 0-3) post-vaccination period following each vaccine dose and across doses
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
Within 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 results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity.
Time Frame
During the entire study period (from Day 0 to Month 3)
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 vaccination.
Born after a gestation period of 36 to 42 weeks inclusive.
Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative (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:
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.
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 exception of DTP, Hib and/or hepatitis B vaccine(s).
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 poliomyelitis 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.
Child in care.
The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved and if no other exclusion criteria are met:
• Current febrile illness or axillary temperature > 37.0 ºC or other moderate to severe illness within 24 hours of study vaccine administration.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Wuzhou
State/Province
Guangxi
Country
China
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=268
Citations:
Citation
Li R et al. Immunogenicity and safety of an inactivated poliovirus vaccine in Chinese infants. Abstract presented at the 7th World Congress for World Society for Pediatric Infectious Diseases (WSPID). The Melbourne, The Australia, 16-19 November 2011.
Results Reference
background
PubMed Identifier
26873055
Citation
Li R, Li CG, Li Y, Liu Y, Zhao H, Chen X, Kuriyakose S, Van Der Meeren O, Hardt K, Hezareh M, Roy-Ghanta S. Primary and booster vaccination with an inactivated poliovirus vaccine (IPV) is immunogenic and well-tolerated in infants and toddlers in China. Vaccine. 2016 Mar 14;34(12):1436-43. doi: 10.1016/j.vaccine.2016.02.010. Epub 2016 Feb 9.
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
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112679
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
112679
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
112679
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
112679
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
112679
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
112679
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 of GlaxoSmithKline Biologicals' Poliorix™ Vaccine
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