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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| POLIORIX GROUP | Experimental | Healthy male or female subjects between, and including, 18 and 24 months of age, received a single booster dose of Poliorixâ„¢ vaccine that was administrated into the upper right thigh by intramuscular injection (IM). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PoliorixTM | Biological | Single dose, intramuscular administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During the 4-day (Days 0-3) post-vaccination period |
| 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. | During the 4-day (Days 0-3) post-vaccination period |
| 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. | During the 31-day (Days 0-30) post-vaccination period |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
The following condition is temporary or self-limiting and a subject may be vaccinated once the condition has resolved and no other exclusion criteria are met:
• Current febrile illness or axillary temperature > 37.0 ºC or other moderate to severe illness within 24 hours of study vaccine administration.
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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 | 543002 | China |
| 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 |
|---|---|---|---|
| 112683 | Clinical Study Report | 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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Out of 26 subjects enrolled in the study, one did not receive any vaccination.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| 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 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. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects with documented administration of the study vaccine. | Posted | Number | Subjects | During the 4-day (Days 0-3) post-vaccination period |
|
Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 1).
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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 | 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). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 12.0 | 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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| During the entire study period (from Day 0 to Month 1) |
For additional information about this study please refer to the GSK Clinical Study Register |
| 112683 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112683 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112683 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112683 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112683 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 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. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects with documented administration of the study vaccine. | Posted | Number | Subjects | During the 4-day (Days 0-3) post-vaccination period |
|
|
|
| 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. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects with documented administration of the study vaccine. | Posted | Number | Subjects | During the 31-day (Days 0-30) post-vaccination period |
|
|
|
| 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. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects with documented administration of the study vaccine. | Posted | Number | Subjects | During the entire study period (from Day 0 to Month 1) |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 14 |
| 25 |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Irritability | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Swelling | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
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 |
| Title | Measurements |
|---|---|
|
| Any Irritability |
|
| Grade 3 Irritability |
|
| Related Irritability |
|
| Any Loss of appetite |
|
| Grade 3 Loss of appetite |
|
| Related Loss of appetite |
|
| Any Temperature |
|
| Grade 3 Temperature |
|
| Related Temperature |
|
| Title | Measurements |
|---|---|
|