Poliomyelitis
Conditions
Keywords
poliomyelitis, diphtheria, Primary immunization, pertussis, Children, tetanus
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.
Interventions
BIOLOGICALPoliorix TM
Intramuscular administration, 3 doses
BIOLOGICALInfanrix TM
Intramuscular administration, 3 doses
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Months to 6 Months
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | During the 4-day (Days 0 - 3) post vaccination period | 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 | During the 4-day (Days 0 - 3) post vaccination period | 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) | During the 31-day (Days 0 - 30) post vaccination period | 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). | During the entire study period (Day 0 - Month 4) | 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. |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Poliorix Group Subjects received 3 primary doses of Poliorix™ and Infanrix™ 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). | 400 |
| Total | 400 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Informed consent withdrawal | 4 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Migration from the study area | 3 |
| Overall Study | Other | 1 |
Baseline characteristics
| Characteristic | Poliorix Group |
|---|---|
| Age, Continuous | 3.40 Months STANDARD_DEVIATION 0.5 |
| Sex: Female, Male Female | 178 Participants |
| Sex: Female, Male Male | 222 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 400 |
| other Total, other adverse events | 258 / 400 |
| serious Total, serious adverse events | 4 / 400 |
Outcome results
Primary
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.
Time frame: During the 4-day (Days 0 - 3) post vaccination period
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Poliorix Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms | [Any Drowsiness] | 227 Subjects |
| Poliorix Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms | [Grade 3 Drowsiness] | 15 Subjects |
| Poliorix Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms | [Any Irritability] | 240 Subjects |
| Poliorix Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms | [Grade 3 Irritability] | 20 Subjects |
| Poliorix Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms | [Any Loss of appetite] | 133 Subjects |
| Poliorix Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms | [Grade 3 Loss of appetite] | 10 Subjects |
| Poliorix Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms | [Any Fever] | 69 Subjects |
| Poliorix Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms | [Grade 3 Fever] | 1 Subjects |
Primary
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)
Time frame: During the 4-day (Days 0 - 3) post vaccination period
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Poliorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | [Any Pain] | 114 Subjects |
| Poliorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | [Grade 3 Pain] | 7 Subjects |
| Poliorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | [Any Redness] | 258 Subjects |
| Poliorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | [Grade 3 Redness] | 12 Subjects |
| Poliorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | [Any Swelling] | 152 Subjects |
| Poliorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | [Grade 3 Swelling] | 8 Subjects |
Primary
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.
Time frame: During the entire study period (Day 0 - Month 4)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Poliorix Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs). | [Any SAEs] | 4 Subjects |
| Poliorix Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs). | [Related SAEs] | 0 Subjects |
Primary
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.
Time frame: During the 31-day (Days 0 - 30) post vaccination period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Poliorix Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | 91 Subjects |