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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Subjects in this group will receive the GSK Biologicals' IPV vaccine at 18 months of age. Subjects will also receive a dose of DTPa/Hib (Infanrix+Hib) as part of the local standard of care. |
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| Group B | Active Comparator | Subjects in this group will receive only a booster dose of GSK Biologicals' DTPa/Hib vaccine (Infanrix+Hib) as part of the local standard of care and will not be associated with any study endpoint. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PoliorixTM | Biological | Single dose, intramuscular administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One month after Poliorix™ booster vaccination. |
| 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. | Before booster vaccination. |
| 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. | One month after Poliorixâ„¢ booster vaccination. |
| Antibody Titers Against Poliovirus Type 1, 2 and 3. | Antibody titers were summarized by geometric mean titers (GMTs) with their 95% CIs. | Before booster vaccination. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Wuzhou | Guangxi | China | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26873055 | Derived | Li R, Li CG, Li Y, Liu Y, Zhao H, Chen X, Kuriyakose S, Van Der Meeren O, Hardt K, Hezareh M, Roy-Ghanta S. Primary and booster vaccination with an inactivated poliovirus vaccine (IPV) is immunogenic and well-tolerated in infants and toddlers in China. Vaccine. 2016 Mar 14;34(12):1436-43. doi: 10.1016/j.vaccine.2016.02.010. Epub 2016 Feb 9. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 114306 | Dataset Specification | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
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| ID | Title | Description |
|---|---|---|
| FG000 | Poliorix Group | Subjects previously primed with 3 doses of Poliorixâ„¢ vaccine in the primary study and who received a booster dose of Poliorixâ„¢ vaccine co-administered with Infanrix-Hibâ„¢ vaccine in the current study. |
| FG001 | 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-Hibâ„¢ vaccine in the current study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Poliorix Group | Subjects previously primed with 3 doses of Poliorixâ„¢ vaccine in the primary study and who received a booster dose of Poliorixâ„¢ vaccine co-administered with Infanrix-Hibâ„¢ vaccine in the current study. |
| BG001 | Control Group |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | One month after Poliorix™ booster vaccination. |
|
Solicited local and general symptoms: during the 4-day (Days 0-3) post-Poliorixâ„¢ booster vaccination period; Unsolicited symptoms: during the 31-day (Days 0-30) post-Poliorixâ„¢ booster vaccination period. Serious Adverse Events (SAEs): during the entire study period (Day 0 to Month 1).
Other (non-serious) adverse events were collected only for those subjects who had received a booster dose of Poliorix, i.e. Poliorix Group. No other (non-serious) adverse events data was collected for the Control Group.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Poliorix Group | Subjects previously primed with 3 doses of Poliorixâ„¢ vaccine in the primary study and who received a booster dose of Poliorixâ„¢ vaccine co-administered with Infanrix-Hibâ„¢ vaccine in the current study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA 17.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D011051 | Poliomyelitis |
| ID | Term |
|---|---|
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D004769 | Enterovirus Infections |
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| ID | Term |
|---|---|
| C541235 | diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine |
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| Infanrix+Hib |
| Biological |
Single dose, intramuscular injection. Part of the local standard of care. No outcome measures associated. |
|
| Within 4-days (Days 0-3) post Poliorixâ„¢ booster vaccination. |
| 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. | Within 4-days (Days 0-3) post Poliorix™ booster vaccination. |
| 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. | Within the 31-day (Days 0-30) follow-up period after the Poliorixâ„¢ booster vaccination. |
| 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. | During the entire study period (Day 0 to Month 1). |
| Mengshan Town |
| China |
For additional information about this study please refer to the GSK Clinical Study Register |
| 114306 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114306 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114306 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114306 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114306 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Lost to Follow-up |
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Subjects previously primed with 3 doses of Chinese oral poliovirus vaccine (OPV) in the primary study and who received a dose of Infanrix-Hibâ„¢ vaccine in the current study. |
| BG002 | Total | Total of all reporting groups |
| Months |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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. | 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 | Posted | Count of Participants | Participants | Before booster vaccination. |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | Titers | One month after Poliorixâ„¢ booster vaccination. |
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| Primary | Antibody Titers Against Poliovirus Type 1, 2 and 3. | Antibody titers were summarized by geometric mean titers (GMTs) with their 95% CIs. | 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 | Posted | Geometric Mean | 95% Confidence Interval | Titers | Before booster vaccination. |
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| 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. | 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. | Posted | Count of Participants | Participants | Within 4-days (Days 0-3) post Poliorixâ„¢ booster vaccination. |
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| 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. | 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. | Posted | Count of Participants | Participants | Within 4-days (Days 0-3) post Poliorix™ booster vaccination. |
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| 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. | The Total Vaccinated cohort included all subjects, with booster dose administration documented and for whom data were available. | Posted | Count of Participants | Participants | Within the 31-day (Days 0-30) follow-up period after the Poliorixâ„¢ booster vaccination. |
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| 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. | The Total Cohort included all subjects enrolled in the study. | Posted | Count of Participants | Participants | During the entire study period (Day 0 to Month 1). |
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| 0 |
| 470 |
| 0 |
| 470 |
| 202 |
| 470 |
| EG001 | 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-Hibâ„¢ vaccine in the current study. | 0 | 487 | 1 | 487 | 0 | 0 |
| Irritability | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA 17.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 17.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D010850 |
| Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |
| Anti-poliovirus 3 |
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| Title | Measurements |
|---|---|
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| Anti-poliovirus 3 |
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| Title | Measurements |
|---|---|
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| Grade 3 Redness |
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| Any Swelling |
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| Grade 3 Swelling |
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| Title | Measurements |
|---|---|
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| Any Irritability |
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| Grade 3 Irritability |
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| Related Irritability |
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| Any Loss of appetite |
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| Grade 3 Loss of appetite |
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| Related Loss of appetite |
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| Any temperature |
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| Grade 3 temperature |
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| Related temperature |
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