Back to resultsStudy to Evaluate the Safety of Co-administration of GSK Biologicals' Poliorix and Infanrix in Healthy Children in Russia
Primary Purpose
Poliomyelitis
Status
Completed
Phase
Phase 4
Locations
Russian Federation
Study Type
Interventional
Intervention
Poliorix TM
Infanrix TM
Sponsored by
About this trial
This is an interventional prevention trial for Poliomyelitis focused on measuring poliomyelitis, diphtheria, Primary immunization, pertussis, Children, tetanus
Eligibility Criteria
Inclusion Criteria:
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female aged 3 months including at the time of the vaccination.
- Written informed consent obtained from the parent of the subject.
- Healthy subjects as established by medical history and clinical examination and thermometry before entering into the study, that don't have contraindications for vaccination against diphtheria, tetanus, pertussis and poliomyelitis
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs from birth.
- Administration of immunoglobulins and/or any blood products from birth or planned administration during the study period.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the vaccination, except recombinant hepatitis B vaccine, Haemophilus influenzae type B vaccine and seasonal/pandemic influenza prophylactic.
- Participation in another clinical study at any time during the study, in which the subject has been or will be exposed to an investigational or a non-registered product (pharmaceutical product or device).
- Previous vaccination against diphtheria, tetanus, pertussis and poliomyelitis if by any reasons it was made in timeframe not stated by National Calendar of Prophylactic Vaccines of Russian Federation.
- Medical history of convulsions and progressive neurological disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination (no laboratory testing required).
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- Chronic diseases and serious congenital defects.
- Acute disease at the time of enrolment.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Poliorix Group
Arm Description
Subjects received 3 primary doses of PoliorixTM and InfanrixTM vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
Outcomes
Primary Outcome Measures
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as considerable pain that prevented normal everyday activities. Grade 3 redness and swelling were defined as redness and swelling greater than (>) 20 millimeters (mm)
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms
Solicited general symptoms assessed were Drowsiness, Irritability, Loss of appetite and Fever [Axillary temperature greater than or equal to (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination. Any fever = oral temperature ≥ 37.5 degrees Celsius (°C). Grade 3 symptoms = symptoms that prevented normal activities. Grade 3 fever = oral temperature > 39.0°C.
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
Unsolicited AE covers any AE 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 occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).
SAEs assessed included medical occurrences that resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01094171
Brief Title
Study to Evaluate the Safety of Co-administration of GSK Biologicals' Poliorix and Infanrix in Healthy Children in Russia
Official Title
A Phase IV (Not Interventional), Open-label, Multicentre Study to Evaluate the Reactogenicity and Safety of Co-administration of GlaxoSmithKline Biologicals' DTPa (Infanrix) and IPV (Poliorix) Vaccines Administered as Three-dose Primary Immunisation Course at 3, 4.5 and 6 Months of Age in Healthy Children in Russian Federation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
December 3, 2010 (Actual)
Primary Completion Date
October 27, 2012 (Actual)
Study Completion Date
October 27, 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 study is to assess reactogenicity and safety of simultaneous administration of GSK Biologicals' inactivated poliomyelitis vaccine Poliorix and GSK Biologicals' DTPa-vaccine Infanrix vaccines in healthy children in Russian Federation in their first year of life according to National Calendar of Prophylactic Immunisation of Russian Federation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Poliomyelitis
Keywords
poliomyelitis, diphtheria, Primary immunization, pertussis, Children, tetanus
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Poliorix Group
Arm Type
Experimental
Arm Description
Subjects received 3 primary doses of PoliorixTM and InfanrixTM vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
Intervention Type
Biological
Intervention Name(s)
Poliorix TM
Intervention Description
Intramuscular administration, 3 doses
Intervention Type
Biological
Intervention Name(s)
Infanrix TM
Intervention Description
Intramuscular administration, 3 doses
Primary Outcome Measure Information:
Title
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Description
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as considerable pain that prevented normal everyday activities. Grade 3 redness and swelling were defined as redness and swelling greater than (>) 20 millimeters (mm)
Time Frame
During the 4-day (Days 0 - 3) post vaccination period
Title
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms
Description
Solicited general symptoms assessed were Drowsiness, Irritability, Loss of appetite and Fever [Axillary temperature greater than or equal to (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination. Any fever = oral temperature ≥ 37.5 degrees Celsius (°C). Grade 3 symptoms = symptoms that prevented normal activities. Grade 3 fever = oral temperature > 39.0°C.
Time Frame
During the 4-day (Days 0 - 3) post vaccination period
Title
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
Description
Unsolicited AE covers any AE 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 occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Time Frame
During the 31-day (Days 0 - 30) post vaccination period
Title
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).
Description
SAEs assessed included medical occurrences that resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Time Frame
During the entire study period (Day 0 - Month 4)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
A male or female aged 3 months including at the time of the vaccination.
Written informed consent obtained from the parent of the subject.
Healthy subjects as established by medical history and clinical examination and thermometry before entering into the study, that don't have contraindications for vaccination against diphtheria, tetanus, pertussis and poliomyelitis
Exclusion Criteria:
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs from birth.
Administration of immunoglobulins and/or any blood products from birth or planned administration during the study period.
Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the vaccination, except recombinant hepatitis B vaccine, Haemophilus influenzae type B vaccine and seasonal/pandemic influenza prophylactic.
Participation in another clinical study at any time during the study, in which the subject has been or will be exposed to an investigational or a non-registered product (pharmaceutical product or device).
Previous vaccination against diphtheria, tetanus, pertussis and poliomyelitis if by any reasons it was made in timeframe not stated by National Calendar of Prophylactic Vaccines of Russian Federation.
Medical history of convulsions and progressive neurological disease.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination (no laboratory testing required).
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
Chronic diseases and serious congenital defects.
Acute disease 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
Barnaul
ZIP/Postal Code
656056
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Ekaterinburg
ZIP/Postal Code
620085
Country
Russian Federation
12. IPD Sharing Statement
Citations:
Citation
Romanenko VV et al. (2016) Safety and reactogenicity of inactivated vaccine for polio prevention (Poliorix ™) output and DTP vaccine (Infanrix ™) in a joint application for trehdozovoy scheme in healthy children in Russia. Ural Med Jq. 9(142):138-144.
Results Reference
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Study to Evaluate the Safety of Co-administration of GSK Biologicals' Poliorix and Infanrix in Healthy Children in Russia
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