Poliomyelitis
Conditions
Keywords
Poliomyelitis Vaccines, IPV
Brief summary
The study will evaluate the safety and reactogenicity of PoliorixTM given as a single booster dose to Chinese children at 18-24 months of age.
Interventions
BIOLOGICALPoliorixTM
Single dose, intramuscular administration.
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Months to 24 Months
Healthy volunteers
Yes
Inclusion criteria
* A male or female toddler between, and including, 18 and 24 months of age at the time of the booster vaccination. * Subjects who received three doses of OPV as primary vaccination in the first year of life as per Chinese recommendations. * 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 within 30 days preceding the booster dose of study vaccine, or planned use during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccination * 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 and/or Hib vaccine(s). * Administration of immunoglobulins and/or any blood products within the three months preceding the booster vaccination, or planned administration during the study period. * 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 * Previous booster vaccination against poliomyelitis since the end of the primary vaccination series. * History of poliomyelitis disease. * 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 vaccines. * 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 With Any and Grade 3 Solicited Local Symptoms | During the 4-day (Days 0-3) post-vaccination period | Assessed solicited local symptoms were pain, redness and swelling. Any = all reports of the specified symptom irrespective 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. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | During the 4-day (Days 0-3) post-vaccination period | Assessed solicited general symptoms were temperature \[defined as axillary temperature equal to or above (≥) 37.1 degrees Celsius (°C)\], drowsiness, irritability and loss of appetite. Any = all reports of the specified symptom irrespective of intensity grade and 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 the vaccination. |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | During the 31-day (Days 0-30) post-vaccination period | 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. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. |
| Number of Subjects With Serious Adverse Events (SAEs) | During the entire study period (from Day 0 to Month 1) | 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. |
Countries
China
Participant flow
Recruitment details
Out of 26 subjects enrolled in the study, one did not receive any vaccination.
Participants by arm
| Arm | Count |
|---|---|
| Poliorix Group Healthy male or female subjects between, and including, 18 and 24 months of age, received a single booster dose of Poliorix vaccine that was administrated into the upper right thigh by intramuscular injection (IM). | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Poliorix Group |
|---|---|
| Age, Continuous | 20.3 Months STANDARD_DEVIATION 1.49 |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 14 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = all reports of the specified symptom irrespective 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.
Time frame: During the 4-day (Days 0-3) post-vaccination period
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with documented administration of the study vaccine.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Poliorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 4 Subjects |
| Poliorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 0 Subjects |
| Poliorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 5 Subjects |
| Poliorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 0 Subjects |
| Poliorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 3 Subjects |
| Poliorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 0 Subjects |
Primary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were temperature \[defined as axillary temperature equal to or above (≥) 37.1 degrees Celsius (°C)\], drowsiness, irritability and loss of appetite. Any = all reports of the specified symptom irrespective of intensity grade and 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 the vaccination.
Time frame: During the 4-day (Days 0-3) post-vaccination period
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with documented administration of the study vaccine.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness | 3 Subjects |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness | 0 Subjects |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness | 3 Subjects |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability | 5 Subjects |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability | 0 Subjects |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability | 3 Subjects |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite | 3 Subjects |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite | 0 Subjects |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite | 2 Subjects |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Temperature | 6 Subjects |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Temperature | 0 Subjects |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Temperature | 5 Subjects |
Primary
Number of Subjects With Any, Grade 3 and Related 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. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time frame: During the 31-day (Days 0-30) post-vaccination period
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with documented administration of the study vaccine.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 10 Subjects |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 0 Subjects |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 0 Subjects |
Primary
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.
Time frame: During the entire study period (from Day 0 to Month 1)
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with documented administration of the study vaccine.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Poliorix Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Subjects |