Clinical Trial Results:
An open-label primary vaccination study to assess the safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ Inactivated Poliomyelitis vaccine (IPV) Poliorix administered as a three-dose primary vaccination course at 2, 3 and 4 months of age in healthy infants in China
Summary
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EudraCT number |
2017-001607-80 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
13 Nov 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 |
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 |
112581
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00937404 | ||
WHO universal trial number (UTN) |
- | ||
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 |
13 Nov 2009
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
13 Nov 2009
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Global end of trial reached? |
Yes
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Global end of trial date |
13 Nov 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 GSK Biologicals’ Poliorix vaccine administered as a three-dose primary vaccination course
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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 |
04 Aug 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 |
- | ||||||||||||
Pre-assignment
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Screening details |
- | ||||||||||||
Pre-assignment period milestones
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Number of subjects started |
25 | ||||||||||||
Number of subjects completed |
25 | ||||||||||||
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 | ||||||||||||
Arms
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Arm title
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IPV Group | ||||||||||||
Arm description |
Healthy male or female subjects between, and including, 60 and 90 days of age at the time of the first vaccination, received 3 doses of Poliorix at 2 (Study Day 0, Visit 1), 3 (Study Month 1, Visit 2) and 4 (Study Month 2, Visit 3) months of age, administered intramuscularly into the upper right side of the thigh. | ||||||||||||
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 three doses of Poliorix vaccine, administered intramuscularly into the upper right side of the thigh
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Baseline characteristics reporting groups
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Reporting group title |
IPV Group
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Reporting group description |
Healthy male or female subjects between, and including, 60 and 90 days of age at the time of the first vaccination, received 3 doses of Poliorix at 2 (Study Day 0, Visit 1), 3 (Study Month 1, Visit 2) and 4 (Study Month 2, Visit 3) months of age, administered intramuscularly into the upper right side of the thigh. | ||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
IPV Group
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Reporting group description |
Healthy male or female subjects between, and including, 60 and 90 days of age at the time of the first vaccination, received 3 doses of Poliorix at 2 (Study Day 0, Visit 1), 3 (Study Month 1, Visit 2) and 4 (Study Month 2, Visit 3) months of age, administered intramuscularly into the upper right side of the thigh. |
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End point title |
Number of subjects reporting solicited local symptoms [1] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom irrespective of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimetres (mm) of injection site.
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End point type |
Primary
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End point timeframe |
During the 4-day follow-up period after each dose of study vaccine.
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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 reporting solicited general symptoms [2] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above (≥) 37.1 degrees Celsius (°C)]. Any = occurrence of symptom regardless of intensity grade of 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 vaccination.
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End point type |
Primary
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End point timeframe |
During the 4-day follow-up period after each dose of study vaccine.
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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 reporting unsolicited adverse events (AEs) [3] | ||||||||
End point description |
Unsolicited AE covers any AE 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 = occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
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End point type |
Primary
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End point timeframe |
During the 31-days follow-up period after each dose of the study vaccine.
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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 reporting serious adverse events (SAEs) [4] | ||||||||
End point description |
SAEs assessed included any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
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End point type |
Primary
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End point timeframe |
During the entire study period (from Dose 1 up to one month following last vaccine dose).
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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 4-day post-vaccination period after each vaccine dose. Unsolicited AEs: during 31-day post-vaccination period after each vaccine dose. SAEs: during entire study period (from Dose 1 up to one month following last vaccine dose)
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
12.1
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Reporting groups
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Reporting group title |
IPV Group
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Reporting group description |
Healthy male or female subjects between, and including, 60 and 90 days of age at the time of the first vaccination, received 3 doses of Poliorix at 2 (Study Day 0, Visit 1), 3 (Study Month 1, Visit 2) and 4 (Study Month 2, Visit 3) months of age, administered intramuscularly into the upper right side of the thigh. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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 |