Poliomyelitis
Conditions
Keywords
IPV, PoliorixTM, China
Brief summary
This study aims to evaluate the persistence of anti-poliovirus antibodies in toddlers aged 18 months who were primed with oral polio vaccine (OPV) or inactivated polio vaccine (IPV) in the primary study. The study will also assess the immunogenicity and reactogenicity of a booster dose of IPV in subjects primed with three doses of IPV.
Detailed description
All subjects will also receive a booster dose of GSK Biologicals' DTPa/Hib vaccine (Infanrix+Hib) at Day 0. This vaccine will be provided as part of the local standard of care and will not be associated with any study endpoint.
Interventions
BIOLOGICALPoliorixTM
Single dose, intramuscular administration
BIOLOGICALInfanrix+Hib
Single dose, intramuscular injection. Part of the local standard of care. No outcome measures associated.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Months to 24 Months
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol. * Subjects who received the complete three-dose primary vaccination course in study NCT01021293. * Healthy male or female toddlers 18 to 24 months of age at the time of Visit 1 (Day 0). * Written informed consent obtained from the parent(s)/ Legally Acceptable Representative(s) of the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion criteria
* Child in care. * Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the booster dose of study vaccine(s), or planned use during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to Visit 1 (Day 0). * Administration of immunoglobulins and/or any blood products within the 3 months preceding Visit 1 (Day 0) or planned administration during the study period. * Administration of a vaccine not foreseen by the study protocol within 30 days of Visit 1 (Day 0) 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. * Evidence of previous booster vaccination against poliomyelitis or the disease since the conclusion visit of Study NCT01021293. * 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. * Major congenital defects or serious chronic illness. * Acute disease and/or fever at the time of enrolment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value | One month after Poliorix™ booster vaccination. | A seroprotected subject was defined as a vaccinated subject whose antibody titer is greater than or equal to (≥) 8 Effective Dose 50 (ED50). This outcome measure concerns subjects in the Poliorix Group only. |
| Antibody Titers Against Poliovirus Type 1, 2 and 3 | One month after Poliorix™ booster vaccination. | Antibody titers were summarized by geometric mean titers (GMTs) with their 95% confidence intervals (CIs). This outcome measure concerns subjects in the Poliorix Group only. |
| Antibody Titers Against Poliovirus Type 1, 2 and 3. | Before booster vaccination. | Antibody titers were summarized by geometric mean titers (GMTs) with their 95% CIs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Within 4-days (Days 0-3) post Poliorix™ booster vaccination. | Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Cry 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 in the Poliorix Group only. |
| Number of Subjects With Serious Adverse Events (SAEs) | During the entire study period (Day 0 to Month 1). | Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Within 4-days (Days 0-3) post Poliorix™ booster vaccination. | Solicited general symptoms assessed include drowsiness, irritability, loss of appetite and fever \[defined as axillary temperature ≥ 37.1 degrees Celsius (°C)\]. Any = occurence of any general symptom regardless of their intensity grade or relationship to study vaccine. Grade 3 drowsiness = drowsiness that prevented normal activities. Grade 3 fever = fever (axillary temperature) \>39.0°C. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as causally related to the vaccination. This outcome measure concerns subjects in the Poliorix Group only. |
| Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | Within the 31-day (Days 0-30) follow-up period after the Poliorix™ booster vaccination. | 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. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. This outcome measure concerns subjects in the Poliorix Group only. |
Countries
China
Participant flow
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 Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study. | 470 |
| Control Group Subjects previously primed with 3 doses of Chinese oral poliovirus vaccine (OPV) in the primary study and who received a dose of Infanrix-Hib™ vaccine in the current study. | 487 |
| Total | 957 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Migrated/moved from study area | 2 | 0 |
| Overall Study | Withdrawal by Subject | 5 | 0 |
Baseline characteristics
| Characteristic | Poliorix Group | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 18.7 Months STANDARD_DEVIATION 0.93 | 18.8 Months STANDARD_DEVIATION 1.01 | 18.75 Months STANDARD_DEVIATION 0.97 |
| Race/Ethnicity, Customized Asian - Chinese heritage | 470 Participants | 487 Participants | 957 Participants |
| Sex: Female, Male Female | 234 Participants | 227 Participants | 461 Participants |
| Sex: Female, Male Male | 236 Participants | 260 Participants | 496 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 470 | 0 / 487 |
| other Total, other adverse events | 202 / 470 | 0 / 0 |
| serious Total, serious adverse events | 0 / 470 | 1 / 487 |
Outcome results
Primary
Antibody Titers Against Poliovirus Type 1, 2 and 3
Antibody titers were summarized by geometric mean titers (GMTs) with their 95% confidence intervals (CIs). This outcome measure concerns subjects in the Poliorix Group only.
Time frame: One month after Poliorix™ booster vaccination.
Population: The ATP cohort for immunogenicity included all evaluable subjects who did not receive a product or present a medical condition leading to exclusion from an ATP analysis as listed in protocol and for whom data concerning immunogenicity outcome variables were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Poliorix Group | Antibody Titers Against Poliovirus Type 1, 2 and 3 | Anti-poliovirus 1 | 3420.8 Titers |
| Poliorix Group | Antibody Titers Against Poliovirus Type 1, 2 and 3 | Anti-poliovirus 2 | 1886.8 Titers |
| Poliorix Group | Antibody Titers Against Poliovirus Type 1, 2 and 3 | Anti-poliovirus 3 | 5097 Titers |
Primary
Antibody Titers Against Poliovirus Type 1, 2 and 3.
Antibody titers were summarized by geometric mean titers (GMTs) with their 95% CIs.
Time frame: Before booster vaccination.
Population: The ATP cohort for antibody persistence included all subjects who completed the full 3-dose primary vaccination course in the primary study and have not received an additional dose of Poliorix vaccine since the primary study.Those who had no history of poliovirus infection,and for whom serological results were available at the persistence timepoint
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Poliorix Group | Antibody Titers Against Poliovirus Type 1, 2 and 3. | Anti-poliovirus 1 | 97.6 Titers |
| Poliorix Group | Antibody Titers Against Poliovirus Type 1, 2 and 3. | Anti-poliovirus 2 | 87.8 Titers |
| Poliorix Group | Antibody Titers Against Poliovirus Type 1, 2 and 3. | Anti-poliovirus 3 | 109.7 Titers |
| Control Group | Antibody Titers Against Poliovirus Type 1, 2 and 3. | Anti-poliovirus 2 | 205.5 Titers |
| Control Group | Antibody Titers Against Poliovirus Type 1, 2 and 3. | Anti-poliovirus 1 | 533.0 Titers |
| Control Group | Antibody Titers Against Poliovirus Type 1, 2 and 3. | Anti-poliovirus 3 | 85.0 Titers |
Primary
Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value
A seroprotected subject was defined as a vaccinated subject whose antibody titer is greater than or equal to (≥) 8 ED50.
Time frame: Before booster vaccination.
Population: The ATP cohort for antibody persistence included all subjects who completed the full 3-dose primary vaccination course in the primary study and have not received an additional dose of Poliorix vaccine since the primary study.Those who had no history of poliovirus infection,and for whom serological results were available at the persistence timepoint
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Poliorix Group | Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value | Anti-poliovirus 1 | 462 Participants |
| Poliorix Group | Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value | Anti-poliovirus 2 | 445 Participants |
| Poliorix Group | Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value | Anti-poliovirus 3 | 446 Participants |
| Control Group | Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value | Anti-poliovirus 1 | 479 Participants |
| Control Group | Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value | Anti-poliovirus 2 | 482 Participants |
| Control Group | Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value | Anti-poliovirus 3 | 465 Participants |
Primary
Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value
A seroprotected subject was defined as a vaccinated subject whose antibody titer is greater than or equal to (≥) 8 Effective Dose 50 (ED50). This outcome measure concerns subjects in the Poliorix Group only.
Time frame: One month after Poliorix™ booster vaccination.
Population: The According-to-Protocol (ATP) cohort for immunogenicity included all evaluable subjects who did not receive a product or present a medical condition leading to exclusion from an ATP analysis as listed in protocol and for whom data concerning immunogenicity outcome variables were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Poliorix Group | Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value | Anti-poliovirus 1 | 456 Participants |
| Poliorix Group | Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value | Anti-poliovirus 2 | 456 Participants |
| Poliorix Group | Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value | Anti-poliovirus 3 | 456 Participants |
Secondary
Number of Subjects Reporting 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. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. This outcome measure concerns subjects in the Poliorix Group only.
Time frame: Within the 31-day (Days 0-30) follow-up period after the Poliorix™ booster vaccination.
Population: The Total Vaccinated cohort included all subjects, with booster dose administration documented and for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Poliorix Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | 22 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Cry 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 in the Poliorix Group only.
Time frame: Within 4-days (Days 0-3) post Poliorix™ booster vaccination.
Population: The Total Vaccinated cohort included all subjects, with booster dose administration documented, for whom data were available and who had their symptom sheets filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Poliorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 49 Participants |
| Poliorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 3 Participants |
| Poliorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 22 Participants |
| Poliorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 0 Participants |
| Poliorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 11 Participants |
| Poliorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 0 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Solicited general symptoms assessed include drowsiness, irritability, loss of appetite and fever \[defined as axillary temperature ≥ 37.1 degrees Celsius (°C)\]. Any = occurence of any general symptom regardless of their intensity grade or relationship to study vaccine. Grade 3 drowsiness = drowsiness that prevented normal activities. Grade 3 fever = fever (axillary temperature) \>39.0°C. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as causally related to the vaccination. This outcome measure concerns subjects in the Poliorix Group only.
Time frame: Within 4-days (Days 0-3) post Poliorix™ booster vaccination.
Population: The Total Vaccinated cohort included all subjects, with booster dose administration documented, for whom data were available and who had their symptom sheets filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any temperature | 156 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Drowsiness | 59 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Drowsiness | 1 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Drowsiness | 59 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Irritability | 86 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Irritability | 2 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Irritability | 84 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Any Loss of appetite | 84 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Loss of appetite | 1 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related Loss of appetite | 83 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 temperature | 8 Participants |
| Poliorix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. | Related temperature | 153 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
Time frame: During the entire study period (Day 0 to Month 1).
Population: The Total Cohort included all subjects enrolled in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Poliorix Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| Control Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |