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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003167-30 | EudraCT Number |
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The purpose of the study is to evaluate the immunogenicity and safety of Poliorixâ„¢ when administered to healthy Chinese infants at 2, 3 and 4 months of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Poliorix Group | Experimental | Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorixâ„¢ (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh. |
|
| Control Group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Poliorixâ„¢ | Biological | 3 doses, intramuscular administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | At Month 3, one month after the third vaccine dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At Day 0, prior to the first vaccine dose |
| Anti-poliovirus Types 1, 2 and 3 Antibody Titers |
Not provided
Inclusion Criteria:
Exclusion Criteria:
The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved and if 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 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Li R et al. Immunogenicity and safety of an inactivated poliovirus vaccine in Chinese infants. Abstract presented at the 7th World Congress for World Society for Pediatric Infectious Diseases (WSPID). The Melbourne, The Australia, 16-19 November 2011. | ||
| 26873055 | Background | 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 |
|---|---|---|---|
| 112679 | Individual Participant Data Set | View IPD |
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Control Group |
| 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 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). | 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. | Posted | Count of Participants | Participants | At Month 3, one month after the third vaccine dose |
|
Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 3).
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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 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA | 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 |
|---|---|
| D011055 | Poliovirus Vaccine, Oral |
| ID | Term |
|---|---|
| D023321 | Poliovirus Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| Oral Poliovirus vaccine |
| Biological |
3 doses, oral administration |
|
Antibody titers were presented as geometric mean titers (GMTs). |
| Prior to the first vaccine dose (Day 0) and one month after the third vaccine dose (Month 3) |
| 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. | During the 4-day (Days 0-3) post-vaccination period following each vaccine dose and across doses |
| 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. | During the 4-day (Days 0-3) post-vaccination period following each vaccine dose and across doses |
| 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. | Within 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 results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity. | During the entire study period (from Day 0 to Month 3) |
For additional information about this study please refer to the GSK Clinical Study Register |
| 112679 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112679 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112679 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112679 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112679 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Withdrawal by Subject |
|
| Migrated/moved from study area |
|
| Lost to Follow-up |
|
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. |
| BG002 | Total | Total of all reporting groups |
| Weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | At Day 0, prior to the first vaccine dose |
|
|
|
| Secondary | Anti-poliovirus Types 1, 2 and 3 Antibody Titers | Antibody titers were presented as geometric mean titers (GMTs). | 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. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Prior to the first vaccine dose (Day 0) and one month after the third vaccine dose (Month 3) |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | During the 4-day (Days 0-3) post-vaccination period following each vaccine dose and across doses |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | During the 4-day (Days 0-3) post-vaccination period following each vaccine dose and across doses |
|
|
|
| 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. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented. | Posted | Count of Participants | Participants | Within the 31-day (Days 0-30) post-vaccination period |
|
|
|
| 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. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented. | Posted | Count of Participants | Participants | During the entire study period (from Day 0 to Month 3) |
|
|
|
| 0 |
| 550 |
| 3 |
| 550 |
| 391 |
| 550 |
| EG001 | 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. | 0 | 550 | 6 | 550 | 366 | 550 |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pain | General disorders | MedDRA | Systematic Assessment |
|
| Redness | General disorders | MedDRA | Systematic Assessment |
|
| Drowsiness | General disorders | MedDRA | Systematic Assessment |
|
| Gastrointestinal symptoms | General disorders | MedDRA | Systematic Assessment |
|
| Irritability/Fussiness | General disorders | MedDRA | Systematic Assessment |
|
| Loss of appetite | General disorders | MedDRA | Systematic Assessment |
|
| Fever (Axillary) | General disorders | MedDRA | 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 |
| D045424 |
| Complex Mixtures |
| Anti-poliovirus 3 |
|
| Anti-poliovirus 2, D0 |
|
| Anti-poliovirus 2, M3 |
|
| Anti-poliovirus 3, D0 |
|
| Anti-poliovirus 3, M3 |
|
|
| Any Redness, Dose 1 |
|
|
| Grade 3 Redness, Dose 1 |
|
|
| Any Swelling, Dose 1 |
|
|
| Grade 3 Swelling, Dose 1 |
|
|
| Any Pain, Dose 2 |
|
|
| Grade 3 Pain, Dose 2 |
|
|
| Any Redness, Dose 2 |
|
|
| Grade 3 Redness, Dose 2 |
|
|
| Any Swelling, Dose 2 |
|
|
| Grade 3 Swelling, Dose 2 |
|
|
| Any Pain, Dose 3 |
|
|
| Grade 3 Pain, Dose 3 |
|
|
| Any Redness, Dose 3 |
|
|
| Grade 3 Redness, Dose 3 |
|
|
| Any Swelling, Dose 3 |
|
|
| Grade 3 Swelling, Dose 3 |
|
|
| Any Pain, Across doses |
|
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| Grade 3 Pain, Across doses |
|
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| Any Redness, Across doses |
|
|
| Grade 3 Redness, Across doses |
|
|
| Any Swelling, Across doses |
|
|
| Grade 3 Swelling, Across doses |
|
|
| Grade 3 Drowsiness, Dose 1 |
|
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| Related Drowsiness, Dose 1 |
|
|
| Any Gastrointestinal Symptoms, Dose 1 |
|
|
| Grade 3 Gastrointestinal, Dose 1 |
|
|
| Related Gastrointestinal, Dose 1 |
|
|
| Any Irritability/Fussiness, Dose 1 |
|
|
| Grade 3 Irritability/Fussiness, Dose 1 |
|
|
| Related Irritability/Fussiness, Dose 1 |
|
|
| Any Loss of appetite, Dose 1 |
|
|
| Grade 3 Loss of appetite, Dose 1 |
|
|
| Related Loss of appetite, Dose 1 |
|
|
| Any temperature, Dose 1 |
|
|
| Grade 3 temperature, Dose 1 |
|
|
| Related temperature, Dose 1 |
|
|
| Any Drowsiness, Dose 2 |
|
|
| Grade 3 Drowsiness, Dose 2 |
|
|
| Related Drowsiness, Dose 2 |
|
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| Any Gastrointestinal, Dose 2 |
|
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| Grade 3 Gastrointestinal, Dose 2 |
|
|
| Related Gastrointestinal, Dose 2 |
|
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| Any Irritability/Fussiness, Dose 2 |
|
|
| Grade 3 Irritability/Fussiness, Dose 2 |
|
|
| Related Irritability/Fussiness, Dose 2 |
|
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| Any Loss of appetite, Dose 2 |
|
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| Grade 3 Loss of appetite, Dose 2 |
|
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| Related Loss of appetite, Dose 2 |
|
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| Any temperature, Dose 2 |
|
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| Grade 3 temperature, Dose 2 |
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| Related temperature, Dose 2 |
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| Any Drowsiness, Dose 3 |
|
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| Grade 3 Drowsiness, Dose 3 |
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| Related Drowsiness, Dose 3 |
|
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| Any Gastrointestinal, Dose 3 |
|
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| Grade 3 Gastrointestinal, Dose 3 |
|
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| Related Gastrointestinal, Dose 3 |
|
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| Any Irritability/Fussiness, Dose 3 |
|
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| Grade 3 Irritability/Fussiness, Dose 3 |
|
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| Related Irritability/Fussiness, Dose 3 |
|
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| Any Loss of appetite, Dose 3 |
|
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| Grade 3 Loss of appetite, Dose 3 |
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| Related Loss of appetite, Dose 3 |
|
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| Any temperature, Dose 3 |
|
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| Grade 3 temperature, Dose 3 |
|
|
| Related temperature, Dose 3 |
|
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| Any Drowsiness, Across doses |
|
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| Grade 3 Drowsiness, Across doses |
|
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| Related Drowsiness, Across doses |
|
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| Any Gastrointestinal, Across doses |
|
|
| Grade 3 Gastrointestinal, Across doses |
|
|
| Related Gastrointestinal, Across doses |
|
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| Any Irritability, Across doses |
|
|
| Grade 3 Irritability, Across doses |
|
|
| Related Irritability, Across doses |
|
|
| Any Loss of appetite, Across doses |
|
|
| Grade 3 Loss of appetite, Across doses |
|
|
| Related Loss of appetite, Across doses |
|
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| Any Fever, Across doses |
|
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| Grade 3 Fever, Across doses |
|
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| Related Fever, Across doses |
|
|