Clinical Trial Results:
A phase IV, open-label, multicentre, non-comparative study to assess reactogenicity and safety of co-administration of GlaxoSmithKline (GSK) Biologicals’ inactivated poliomyelitis vaccine PoliorixTM and DTPa-vaccine InfanrixTM in frame of three-doses primary immunization course in healthy children of 3, 4.5 and 6 months on age in Russian Federation.
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Summary
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EudraCT number |
2013-002804-15 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
27 Oct 2012
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Results information
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Results version number |
v2(current) |
This version publication date |
21 Oct 2020
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First version publication date |
11 Jul 2015
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Other versions |
v1 |
Version creation reason |
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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 |
113586
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01094171 | ||
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, B-1330
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Public contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089904466, GSKClinicalSupportHD@gsk.com
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Scientific contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089904466, 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 |
26 Oct 2013
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
27 Oct 2012
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Global end of trial reached? |
Yes
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Global end of trial date |
27 Oct 2012
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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 |
Reactogenicity and safety assessment of co-administration of GlaxoSmithKline (GSK) Biologicals’ inactivated poliomyelitis vaccine PoliorixTM and GlaxoSmithKline (GSK) Biologicals’ DTPa-vaccine InfanrixTM in frame of three-doses primary im-munization course in healthy children of 3, 4.5 and 6 months on age in Russian Federation.
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Protection of trial subjects |
All subjects were observed closely for at least 30 minutes with appropriate medical treatment readily available in case of a rare anaphylactic reaction following the administration of the vaccine.
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Background therapy |
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Evidence for comparator |
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Actual start date of recruitment |
03 Dec 2010
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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 |
Russian Federation: 400
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Worldwide total number of subjects |
400
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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) |
400
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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 |
- | ||||||||||||||||
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Pre-assignment
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Screening details |
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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Period 1
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Period 1 title |
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 |
Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix). | ||||||||||||||||
Arm type |
Experimental | ||||||||||||||||
Investigational medicinal product name |
Poliorix™
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Investigational medicinal product code |
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Other name |
IPV
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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 |
Three doses administered intramuscularly in the anterolateral side of the left thigh.
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Investigational medicinal product name |
Infanrix™
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Investigational medicinal product code |
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Other name |
DTPa
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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 |
Three doses administered intramuscularly in the anterolateral side the right thigh.
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Baseline characteristics reporting groups
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Reporting group title |
Poliorix Group
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Reporting group description |
Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Poliorix Group
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Reporting group description |
Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix). | ||
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End point title |
Number of subjects reporting any and grade 3 solicited local symptoms [1] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as considerable pain that prevented normal everyday activities. Grade 3 redness and swelling were defined as redness and swelling greater than (>) 20 millimeters (mm)
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End point type |
Primary
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End point timeframe |
During 4 days follow-up period (i.e. the day of vaccination and 3 following days) after administration of each vaccine dose.
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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 analysis of the primary endpoint was descriptive i.e. 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 any and grade 3 solicited general symptoms [2] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Solicited general symptoms assessed were Drowsiness, Irritability, Loss of appetite and Fever [Axillary temperature greater than or equal to (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination. Any fever = oral temperature ≥ 37.5 degrees Celsius (°C). Grade 3 symptoms = symptoms that prevented normal activities. Grade 3 fever = oral temperature > 39.0°C.
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End point type |
Primary
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End point timeframe |
During 31 days follow-up period (i.e. the day of vaccination and 30 following days) after administration of each vaccine dose.
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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 analysis of the primary endpoint was descriptive i.e. 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 any 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 was defined as 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 31 days follow-up period (i.e. the day of vaccination and 30 following days) after administration of each vaccine dose.
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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 analysis of the primary endpoint was descriptive i.e. 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 |
SAEs assessed included medical occurrences that resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
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End point type |
Primary
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End point timeframe |
During the entire study period (Day 0-Month 4).
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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 analysis of the primary endpoint was descriptive i.e. 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 |
Serious Adverse Events: From Day 0 to Month 4; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 31-day (Days 0-30) post-vaccination period.
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Adverse event reporting additional description |
The number of occurrences reported for solicited symptoms, adverse events, and serious adverse events were not available for posting. The number of subjects affected by each specific event was indicated as the number of occurrences.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
16.0
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Reporting groups
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Reporting group title |
Poliorix Group
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Reporting group description |
Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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. | |||
| A consolidated analysis of all expected and unexpected AEs was not technically possible, therefore the Total #Participants Affected in OAE Table is currently populated by the highest value of #Participants affected within OAE table. | |||
