Poliomyelitis, Poliomyelitis Vaccines
Conditions
Keywords
Poliorix, IPV
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.
Interventions
BIOLOGICALPoliorix™
3 doses, intramuscular administration
BIOLOGICALOral Poliovirus vaccine
3 doses, oral administration
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | At Month 3, one month after the third vaccine dose | 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
| Measure | Time frame | Description |
|---|---|---|
| Anti-poliovirus Types 1, 2 and 3 Antibody Titers | Prior to the first vaccine dose (Day 0) and one month after the third vaccine dose (Month 3) | Antibody titers were presented as geometric mean titers (GMTs). |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 4-day (Days 0-3) post-vaccination period following each vaccine dose and across doses | 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 Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | At Day 0, prior to the first vaccine dose | A seroprotected subject was defined as a vaccinated subject with anti-poliovirus types 1, 2 and 3 titers ≥ 8 ED50. |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) | Within 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. |
| Number of Subjects With Serious Adverse Events (SAEs) | During the entire study period (from Day 0 to Month 3) | 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. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | During the 4-day (Days 0-3) post-vaccination period following each vaccine dose and across doses | 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. |
Countries
China
Participant flow
Recruitment details
Of the 1101 enrolled subjects, one subject was not randomised and administered any vaccine as the parents of the subject refused to vaccinate their child after blood collection at Visit 1 and withdrew their consent.
Pre-assignment details
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Participants by arm
| Arm | Count |
|---|---|
| Poliorix Group 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. | 550 |
| Control Group 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. | 550 |
| Total | 1,100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Migrated/moved from study area | 6 | 18 |
| Overall Study | Serious Adverse Event | 2 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | Poliorix Group | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 10 Weeks STANDARD_DEVIATION 1.16 | 10.1 Weeks STANDARD_DEVIATION 1.18 | 10.05 Weeks STANDARD_DEVIATION 1.17 |
| Race/Ethnicity, Customized Asian-Chinese heritage | 550 Participants | 550 Participants | 1100 Participants |
| Sex: Female, Male Female | 268 Participants | 259 Participants | 527 Participants |
| Sex: Female, Male Male | 282 Participants | 291 Participants | 573 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 550 | 0 / 550 |
| other Total, other adverse events | 391 / 550 | 366 / 550 |
| serious Total, serious adverse events | 3 / 550 | 6 / 550 |
Outcome results
Primary
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).
Time frame: At Month 3, one month after the third vaccine dose
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Poliorix Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-poliovirus 1 | 306 Participants |
| Poliorix Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-poliovirus 2 | 306 Participants |
| Poliorix Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-poliovirus 3 | 306 Participants |
| Control Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-poliovirus 1 | 296 Participants |
| Control Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-poliovirus 2 | 296 Participants |
| Control Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-poliovirus 3 | 291 Participants |
Comparison: Non-inferiority of Poliorix™ as compared to OPV95% CI: [-1.28, 1.24]
Comparison: Non-inferiority of Poliorix™ as compared to OPV95% CI: [-1.28, 1.24]
Comparison: Non-inferiority of Poliorix™ as compared to OPV95% CI: [-3.9, -0.44]
Secondary
Anti-poliovirus Types 1, 2 and 3 Antibody Titers
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)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Poliorix Group | Anti-poliovirus Types 1, 2 and 3 Antibody Titers | Anti-poliovirus 1, M3 | 485.1 Titers |
| Poliorix Group | Anti-poliovirus Types 1, 2 and 3 Antibody Titers | Anti-poliovirus 2, M3 | 234.3 Titers |
| Poliorix Group | Anti-poliovirus Types 1, 2 and 3 Antibody Titers | Anti-poliovirus 1, D0 | 8.7 Titers |
| Poliorix Group | Anti-poliovirus Types 1, 2 and 3 Antibody Titers | Anti-poliovirus 3, D0 | 5.2 Titers |
| Poliorix Group | Anti-poliovirus Types 1, 2 and 3 Antibody Titers | Anti-poliovirus 2, D0 | 6.5 Titers |
| Poliorix Group | Anti-poliovirus Types 1, 2 and 3 Antibody Titers | Anti-poliovirus 3, M3 | 824.3 Titers |
| Control Group | Anti-poliovirus Types 1, 2 and 3 Antibody Titers | Anti-poliovirus 3, M3 | 423.4 Titers |
| Control Group | Anti-poliovirus Types 1, 2 and 3 Antibody Titers | Anti-poliovirus 1, D0 | 7.8 Titers |
| Control Group | Anti-poliovirus Types 1, 2 and 3 Antibody Titers | Anti-poliovirus 1, M3 | 2817 Titers |
| Control Group | Anti-poliovirus Types 1, 2 and 3 Antibody Titers | Anti-poliovirus 2, D0 | 7.2 Titers |
| Control Group | Anti-poliovirus Types 1, 2 and 3 Antibody Titers | Anti-poliovirus 2, M3 | 468.5 Titers |
| Control Group | Anti-poliovirus Types 1, 2 and 3 Antibody Titers | Anti-poliovirus 3, D0 | 5.2 Titers |
Secondary
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.
Time frame: At Day 0, prior to the first vaccine dose
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Poliorix Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-poliovirus 1 | 131 Participants |
| Poliorix Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-poliovirus 2 | 93 Participants |
| Poliorix Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-poliovirus 3 | 48 Participants |
| Control Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-poliovirus 1 | 113 Participants |
| Control Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-poliovirus 2 | 99 Participants |
| Control Group | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 | Anti-poliovirus 3 | 52 Participants |
Secondary
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.
Time frame: During the 4-day (Days 0-3) post-vaccination period following each vaccine dose and across doses
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had filled in their symptom sheets.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Poliorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 1 Participants |
| Poliorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 80 Participants |
| Poliorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 1 Participants |
| Poliorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 20 Participants |
| Poliorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| Poliorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 9 Participants |
| Poliorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| Poliorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 58 Participants |
| Poliorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 2 Participants |
| Poliorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 23 Participants |
| Poliorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 1 Participants |
| Poliorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 8 Participants |
| Poliorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 3 | 41 Participants |
| Poliorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 3 | 0 Participants |
| Poliorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 3 | 15 Participants |
| Poliorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 3 | 0 Participants |
| Poliorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 3 | 6 Participants |
| Poliorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 3 | 0 Participants |
| Poliorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 113 Participants |
| Poliorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 3 Participants |
| Poliorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 46 Participants |
| Poliorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 1 Participants |
| Poliorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 18 Participants |
| Poliorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 1 Participants |
Secondary
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.
Time frame: During the 4-day (Days 0-3) post-vaccination period following each vaccine dose and across doses
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had filled in their symptom sheets.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 3 | 47 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability/Fussiness, Dose 1 | 130 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 3 | 2 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 2 | 2 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 3 | 36 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 1 | 0 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 3 | 46 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 2 | 51 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 3 | 3 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 1 | 82 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 3 | 16 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 2 | 66 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability/Fussiness, Dose 3 | 87 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 1 | 44 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability/Fussiness, Dose 3 | 2 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 2 | 2 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability/Fussiness, Dose 3 | 77 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 1 | 0 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 3 | 52 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 2 | 32 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 3 | 0 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal Symptoms, Dose 1 | 102 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 3 | 34 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability/Fussiness, Dose 2 | 121 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any temperature, Dose 3 | 33 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 1 | 54 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 temperature, Dose 3 | 0 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability/Fussiness, Dose 2 | 7 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related temperature, Dose 3 | 18 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability/Fussiness, Dose 1 | 160 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Across doses | 140 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability/Fussiness, Dose 2 | 105 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Across doses | 4 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any temperature, Dose 1 | 39 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Across doses | 115 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 2 | 70 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Across doses | 154 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 1 | 71 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Across doses | 5 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 2 | 3 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Across doses | 76 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 temperature, Dose 1 | 0 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Across doses | 244 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 2 | 48 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Across doses | 10 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability/Fussiness, Dose 1 | 1 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Across doses | 214 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any temperature, Dose 2 | 39 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Across doses | 147 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related temperature, Dose 1 | 28 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Across doses | 3 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 temperature, Dose 2 | 2 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Across doses | 109 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 1 | 0 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across doses | 99 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related temperature, Dose 2 | 29 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across doses | 2 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 2 | 68 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across doses | 68 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 1 | 99 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across doses | 36 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 1 | 75 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 1 | 1 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 1 | 51 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal Symptoms, Dose 1 | 89 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 1 | 2 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 1 | 43 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability/Fussiness, Dose 1 | 151 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability/Fussiness, Dose 1 | 5 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability/Fussiness, Dose 1 | 105 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 1 | 83 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 1 | 1 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 1 | 47 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any temperature, Dose 1 | 20 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 temperature, Dose 1 | 0 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related temperature, Dose 1 | 10 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 2 | 50 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 2 | 0 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 2 | 25 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 2 | 67 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 2 | 1 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 2 | 35 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability/Fussiness, Dose 2 | 86 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability/Fussiness, Dose 2 | 2 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability/Fussiness, Dose 2 | 50 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 2 | 78 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 2 | 0 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 2 | 47 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any temperature, Dose 2 | 26 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 temperature, Dose 2 | 1 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related temperature, Dose 2 | 11 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 3 | 45 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 3 | 1 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 3 | 25 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 3 | 67 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 3 | 0 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 3 | 25 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability/Fussiness, Dose 3 | 72 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability/Fussiness, Dose 3 | 2 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability/Fussiness, Dose 3 | 44 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 3 | 64 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 3 | 0 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 3 | 36 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any temperature, Dose 3 | 32 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 temperature, Dose 3 | 2 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related temperature, Dose 3 | 17 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Across doses | 125 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Across doses | 2 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Across doses | 80 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Across doses | 156 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Across doses | 3 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Across doses | 87 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Across doses | 216 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Across doses | 9 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Across doses | 159 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Across doses | 168 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Across doses | 1 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Across doses | 109 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across doses | 71 Participants |
| Control Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across doses | 3 Participants |
Secondary
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.
Time frame: Within the 31-day (Days 0-30) post-vaccination period
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Poliorix Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 155 Participants |
| Control Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 162 Participants |
Secondary
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.
Time frame: During the entire study period (from Day 0 to Month 3)
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Poliorix Group | Number of Subjects With Serious Adverse Events (SAEs) | 3 Participants |
| Control Group | Number of Subjects With Serious Adverse Events (SAEs) | 6 Participants |