Clinical Trial Results:
An open-label study to assess the safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ Inactivated Poliomyelitis Vaccine (IPV) Poliorix administered as a booster dose at 18-24 months of age in healthy toddlers in China
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Summary
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EudraCT number |
2017-001608-32 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
03 Aug 2009
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Results information
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Results version number |
v1(current) |
This version publication date |
05 Jan 2018
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First version publication date |
05 Jan 2018
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
112683
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00920439 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
GlaxoSmithKline Biologicals
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Sponsor organisation address |
Rue de l'Institut 89, Rixensart, Belgium, 1330
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Public contact |
Clinical Disclosure Advisor, GlaxoSmithKline Biologicals, ((44)2089) 904466, GSKClinicalSupportHD@gsk.com
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Scientific contact |
Clinical Disclosure Advisor, GlaxoSmithKline Biologicals, ((44)2089) 904466, GSKClinicalSupportHD@gsk.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
03 Aug 2009
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
03 Aug 2009
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Global end of trial reached? |
Yes
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Global end of trial date |
03 Aug 2009
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To assess the safety and reactogenicity of a booster dose of GSK Biologicals' IPV in toddlers
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Protection of trial subjects |
All subjects will be observed closely for at least 30 minutes, with appropriate medical treatment readily available in case of a rare anaphylactic reaction following the administration of vaccines
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
23 Jun 2009
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
China: 25
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Worldwide total number of subjects |
25
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
25
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Out of 26 subjects enrolled in the study, one did not receive any vaccination. | ||||||
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Pre-assignment
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Screening details |
- | ||||||
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Pre-assignment period milestones
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Number of subjects started |
25 | ||||||
Number of subjects completed |
25 | ||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
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Arms
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Arm title
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Poliorix Group | ||||||
Arm description |
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). | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Poliorix
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
All subjects received a single booster dose of Poliorix vaccine
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Baseline characteristics reporting groups
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Reporting group title |
Poliorix Group
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Reporting group description |
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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End points reporting groups
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Reporting group title |
Poliorix Group
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Reporting group description |
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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End point title |
Number of subjects with any and Grade 3 solicited local symptoms [1] | ||||||||||||||||||
End point description |
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.
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End point type |
Primary
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End point timeframe |
During the 4-day (Days 0-3) post-vaccination period
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. |
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Number of subjects with any, Grade 3 and related solicited general symptoms [2] | ||||||||||||||||||||||||||||||
End point description |
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.
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End point type |
Primary
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End point timeframe |
During the 4-day (Days 0-3) post-vaccination period
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
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End point title |
Number of subjects with any, Grade 3 and related unsolicited adverse events (AEs) [3] | ||||||||||||
End point description |
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.
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End point type |
Primary
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End point timeframe |
During the 31-day (Days 0-30) post-vaccination period
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| Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Number of subjects with serious adverse events (SAEs) [4] | ||||||||
End point description |
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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End point type |
Primary
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End point timeframe |
During the entire study period (from Day 0 to Month 1)
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| Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The scope of this end point was descriptive, no statistical hypothesis test was performed. |
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| No statistical analyses for this end point | |||||||||
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Adverse events information
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Timeframe for reporting adverse events |
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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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
12.0
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Reporting groups
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Reporting group title |
Poliorix Group
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Reporting group description |
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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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
