Poliomyelitis
Conditions
Keywords
IPV
Brief summary
The study will evaluate the safety and reactogenicity of Poliorix given as primary vaccination course to Chinese children at 2, 3 and 4 months of age.
Interventions
BIOLOGICALPoliorix
All subjects receive three doses of Poliorix vaccine, administered intramuscularly into the upper right side of the thigh.
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Days to 90 Days
Healthy volunteers
Yes
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 parents/ guardians can and will comply with the requirements of the protocol should be enrolled in the study. * Written informed consent obtained from the parent or guardian 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 allergic disease or reactions 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Solicited Local Symptoms | During the 4-day follow-up period after each dose of study vaccine. | Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom irrespective of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimetres (mm) of injection site. |
| Number of Subjects Reporting Solicited General Symptoms | During the 4-day follow-up period after each dose of study vaccine. | Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever \[defined as axillary temperature equal to or above (≥) 37.1 degrees Celsius (°C)\]. Any = occurrence of symptom regardless of intensity grade of 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 fever = fever above (\>) 39.0°C. Related = symptom assessed by the investigator as related to vaccination. |
| Number of Subjects Reporting Unsolicited Adverse Events (AEs) | During the 31-days follow-up period after each dose of the study vaccine. | 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 = occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. |
| Number of Subjects Reporting Serious Adverse Events (SAEs) | During the entire study period (from Dose 1 up to one month following last vaccine dose). | SAEs assessed included any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IPV Group Healthy male or female subjects between, and including, 60 and 90 days of age at the time of the first vaccination, received 3 doses of Poliorix at 2 (Study Day 0, Visit 1), 3 (Study Month 1, Visit 2) and 4 (Study Month 2, Visit 3) months of age, administered intramuscularly into the upper right side of the thigh. | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | IPV Group |
|---|---|
| Age, Continuous | 9.6 Weeks STANDARD_DEVIATION 1.38 |
| Race/Ethnicity, Customized Asian-Chinese Heritage | 25 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 20 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
Number of Subjects Reporting Serious Adverse Events (SAEs)
SAEs assessed included any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: During the entire study period (from Dose 1 up to one month following last vaccine dose).
Population: Analysis was performed on the Total Vaccinated Cohort, which included all subjects with documented administration of at least one dose of the study vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IPV Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 0 Participants |
Primary
Number of Subjects Reporting Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever \[defined as axillary temperature equal to or above (≥) 37.1 degrees Celsius (°C)\]. Any = occurrence of symptom regardless of intensity grade of 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 fever = fever above (\>) 39.0°C. Related = symptom assessed by the investigator as related to vaccination.
Time frame: During the 4-day follow-up period after each dose of study vaccine.
Population: Analysis was performed on the Total Vaccinated Cohort, which included all subjects with documented administration of at least one dose of the study vaccine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Loss of appetite, Dose 3 | 0 Participants |
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Related Loss of appetite, Dose 3 | 3 Participants |
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Any Drowsiness, Across doses | 8 Participants |
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Any Irritability, Across doses | 14 Participants |
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Irritability, Across doses | 2 Participants |
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Related Loss of appetite, Across doses | 8 Participants |
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Fever, Across doses | 0 Participants |
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Related Drowsiness, Across doses | 8 Participants |
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Any Fever, Across doses | 12 Participants |
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Related Fever, Across doses | 9 Participants |
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Any Fever, Dose 3 | 4 Participants |
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Fever, Dose 3 | 0 Participants |
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Related Fever, Dose 3 | 2 Participants |
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Drowsiness, Across doses | 0 Participants |
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Related Irritability, Across doses | 12 Participants |
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Any Loss of appetite, Across doses | 9 Participants |
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Loss of appetite, Across doses | 0 Participants |
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Any Drowsiness, Dose 1 | 7 Participants |
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Drowsiness, Dose 1 | 0 Participants |
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Related Drowsiness, Dose 1 | 7 Participants |
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Any Irritability, Dose 1 | 10 Participants |
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Irritability, Dose 1 | 0 Participants |
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Related Irritability, Dose 1 | 10 Participants |
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Any Loss of appetite, Dose 1 | 7 Participants |
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Loss of appetite, Dose 1 | 0 Participants |
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Related Loss of appetite, Dose 1 | 7 Participants |
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Any Fever, Dose 1 | 8 Participants |
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Fever, Dose 1 | 0 Participants |
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Related Fever, Dose 1 | 6 Participants |
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Any Drowsiness, Dose 2 | 2 Participants |
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Drowsiness, Dose 2 | 0 Participants |
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Related Drowsiness, Dose 2 | 2 Participants |
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Any Irritability, Dose 2 | 7 Participants |
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Irritability, Dose 2 | 0 Participants |
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Related Irritability, Dose 2 | 6 Participants |
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Any Loss of appetite, Dose 2 | 4 Participants |
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Loss of appetite, Dose 2 | 0 Participants |
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Related Loss of appetite, Dose 2 | 3 Participants |
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Any Fever, Dose 2 | 3 Participants |
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Fever, Dose 2 | 0 Participants |
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Related Fever, Dose 2 | 3 Participants |
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Any Drowsiness, Dose 3 | 3 Participants |
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Drowsiness, Dose 3 | 0 Participants |
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Related Drowsiness, Dose 3 | 1 Participants |
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Any Irritability, Dose 3 | 7 Participants |
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Irritability, Dose 3 | 2 Participants |
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Related Irritability, Dose 3 | 3 Participants |
| IPV Group | Number of Subjects Reporting Solicited General Symptoms | Any Loss of appetite, Dose 3 | 6 Participants |
Primary
Number of Subjects Reporting Solicited Local Symptoms
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom irrespective of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimetres (mm) of injection site.
Time frame: During the 4-day follow-up period after each dose of study vaccine.
Population: Analysis was performed on the Total Vaccinated Cohort, which included all subjects with documented administration of at least one dose of the study vaccine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IPV Group | Number of Subjects Reporting Solicited Local Symptoms | Any Pain, Dose 1 | 1 Participants |
| IPV Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| IPV Group | Number of Subjects Reporting Solicited Local Symptoms | Any Redness, Dose 1 | 2 Participants |
| IPV Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| IPV Group | Number of Subjects Reporting Solicited Local Symptoms | Any Swelling, Dose 1 | 1 Participants |
| IPV Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| IPV Group | Number of Subjects Reporting Solicited Local Symptoms | Any Pain, Dose 2 | 2 Participants |
| IPV Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| IPV Group | Number of Subjects Reporting Solicited Local Symptoms | Any Redness, Dose 2 | 1 Participants |
| IPV Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| IPV Group | Number of Subjects Reporting Solicited Local Symptoms | Any Swelling, Dose 2 | 1 Participants |
| IPV Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| IPV Group | Number of Subjects Reporting Solicited Local Symptoms | Any Pain, Dose 3 | 1 Participants |
| IPV Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Pain, Dose 3 | 0 Participants |
| IPV Group | Number of Subjects Reporting Solicited Local Symptoms | Any Redness, Dose 3 | 0 Participants |
| IPV Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Redness, Dose 3 | 0 Participants |
| IPV Group | Number of Subjects Reporting Solicited Local Symptoms | Any Swelling, Dose 3 | 0 Participants |
| IPV Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Swelling, Dose 3 | 0 Participants |
| IPV Group | Number of Subjects Reporting Solicited Local Symptoms | Any Pain, Across doses | 3 Participants |
| IPV Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Pain, Across doses | 0 Participants |
| IPV Group | Number of Subjects Reporting Solicited Local Symptoms | Any Redness, Across doses | 2 Participants |
| IPV Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Redness, Across doses | 0 Participants |
| IPV Group | Number of Subjects Reporting Solicited Local Symptoms | Any Swelling, Across doses | 2 Participants |
| IPV Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Swelling, Across doses | 0 Participants |
Primary
Number of Subjects Reporting 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 = occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Time frame: During the 31-days follow-up period after each dose of the study vaccine.
Population: Analysis was performed on the Total Vaccinated Cohort, which included all subjects with documented administration of at least one dose of the study vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IPV Group | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | 15 Participants |