Clinical Trial Results:
An open-label study to assess the immunogenicity and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ IPV vaccine (Poliorix) administered as a booster dose at 18 months of age in healthy Chinese toddlers previously primed with the same vaccine in the study IPV-018 (NCT01323647).
Summary
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EudraCT number |
2012-004513-14 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
19 Sep 2011
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Results information
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Results version number |
v1 |
This version publication date |
08 Apr 2016
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First version publication date |
12 Jul 2015
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Other versions |
v2 |
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 |
114306
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01323647 | ||
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, B-1330
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Public contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
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Scientific contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 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 |
25 Jun 2014
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
19 Sep 2011
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Global end of trial reached? |
Yes
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Global end of trial date |
19 Sep 2011
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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 immunological response to a booster dose of GSK Biologicals’ IPV in terms of poliovirus type 1, 2 and 3 antibodies, one month after the booster dose in subjects primed with three doses of the same IPV in study IPV-018.
• To assess the persistence of antibodies to poliovirus types 1, 2 and 3 antigens at 18 months of age in subjects primed with three doses of GSK Biologicals’ IPV or three doses of OPV in study IPV-018.
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Protection of trial subjects |
The 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 vaccine.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
25 Apr 2011
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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: 957
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Worldwide total number of subjects |
957
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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) |
957
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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 |
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms. | |||||||||||||||||||||
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 |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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IPV Group | |||||||||||||||||||||
Arm description |
Subjects previously primed with 3 doses of IPV vaccine in the primary study and who received a booster dose of IPV vaccine co-administered with DTPa/Hib vaccine in the current study. | |||||||||||||||||||||
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 |
One dose administered intramuscularly into the anterolateral side of the thigh.
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Investigational medicinal product name |
Infanrix-Hib™
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and suspension for suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Single dose administered intramuscularly into the anterolateral side of the thigh. Part of the local standard of care. No outcome measures associated.
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Arm title
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Control Group | |||||||||||||||||||||
Arm description |
Subjects previously primed with 3 doses of Chinese OPV vaccine in the primary study and who received a dose of DTPa/Hib vaccine in the current study. | |||||||||||||||||||||
Arm type |
Active comparator | |||||||||||||||||||||
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 |
One dose administered intramuscularly into the anterolateral side of the thigh.
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Investigational medicinal product name |
Infanrix-Hib™
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and suspension for suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Single dose administered intramuscularly into the anterolateral side of the thigh. Part of the local standard of care. No outcome measures associated.
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Baseline characteristics reporting groups
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Reporting group title |
IPV Group
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Reporting group description |
Subjects previously primed with 3 doses of IPV vaccine in the primary study and who received a booster dose of IPV vaccine co-administered with DTPa/Hib vaccine in the current study. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Control Group
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Reporting group description |
Subjects previously primed with 3 doses of Chinese OPV vaccine in the primary study and who received a dose of DTPa/Hib vaccine in the current study. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
IPV Group
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Reporting group description |
Subjects previously primed with 3 doses of IPV vaccine in the primary study and who received a booster dose of IPV vaccine co-administered with DTPa/Hib vaccine in the current study. | ||
Reporting group title |
Control Group
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Reporting group description |
Subjects previously primed with 3 doses of Chinese OPV vaccine in the primary study and who received a dose of DTPa/Hib vaccine in the current study. |
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End point title |
Number of subjects seroprotected for poliovirus types 1, 2 and 3 antibodies above the cut-off value. [1] [2] | ||||||||||||
End point description |
A seroprotected subject was defined as a vaccinated subject whose antibody titer is greater than or equal to (≥) 8 ED50. This outcome measure concerns subjects in the IPV Group only.
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End point type |
Primary
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End point timeframe |
One month after IPV booster vaccination.
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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. [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This outcome measure concerns subjects in the IPV Group only. |
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No statistical analyses for this end point |
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End point title |
Number of subjects seroprotected for poliovirus types 1, 2 and 3 antibodies above the cut-off value. [3] | ||||||||||||||||||
End point description |
A seroprotected subject was defined as a vaccinated subject whose antibody titer is greater than or equal to (≥) 8 ED50.
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End point type |
Primary
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End point timeframe |
Before booster vaccination.
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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 |
Antibody titres against poliovirus type 1, 2 and 3. [4] [5] | ||||||||||||||
End point description |
Antibody titers were summarized by geometric mean titers (GMTs) with their 95% CIs. This outcome measure concerns subjects in the IPV Group only.
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End point type |
Primary
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End point timeframe |
One month after IPV booster vaccination.
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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. [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This outcome measure concerns subjects in the IPV Group only. |
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No statistical analyses for this end point |
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End point title |
Antibody titres against poliovirus type 1, 2 and 3. [6] | |||||||||||||||||||||
End point description |
Antibody titers were summarized by geometric mean titers (GMTs) with their 95% CIs.
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End point type |
Primary
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End point timeframe |
Before booster vaccination.
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Notes [6] - 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 any and grade 3 solicited local symptoms. [7] | ||||||||||||||||||
End point description |
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 pain = Cry 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 in the IPV Group only.
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End point type |
Secondary
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End point timeframe |
Within 4-days (Days 0-3) post IPV booster vaccination.
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Notes [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This outcome measure concerns subjects in the IPV Group only. |
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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. [8] | ||||||||||||||||||||||||||||||
End point description |
Solicited general symptoms assessed include drowsiness, irritability, loss of appetite and fever (defined as axillary temperature ≥37.0°C). Any was defined as incidence of the specified symptoms regardless of intensity or relationship to study vaccine. Grade 3 drowsiness was defined as drowsiness that prevents normal activities. Grade 3 fever was defined as fever (axillary temperature) >39.0°C. Grade 3 irritability was defined as crying more than usual/ interferes with normal activities. Grade 3 loss of appetite was defined as not eating at all. Related = symptom assessed by the investigator as related to the vaccination. This outcome measure concerns subjects only in the IPV Group.
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End point type |
Secondary
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End point timeframe |
Within 4-days (Days 0-3) post IPV booster vaccination.
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Notes [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This outcome measure concerns subjects only in the IPV Group. |
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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 event (AE). [9] | ||||||||
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. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. This outcome measure concerns subjects in the IPV Group only.
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End point type |
Secondary
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End point timeframe |
Within the 31-day follow-up period after the IPV booster vaccination.
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Notes [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This outcome measure concerns subjects in the IPV Group only. |
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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). | ||||||||||||
End point description |
Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
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End point type |
Secondary
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End point timeframe |
During the entire study period (Day 0 to Month 01).
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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: during the entire study period (Day 0 to Month 01); Solicited local and general symptoms: during the 4-day (Days 0-3) post-booster vaccination period; Unsolicited symptoms: within 31 days after IPV booster vaccination.
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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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
17.0
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Reporting groups
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Reporting group title |
IPV Group
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Reporting group description |
Subjects previously primed with 3 doses of IPV vaccine in the primary study and who received a booster dose of IPV vaccine co-administered with DTPa/Hib vaccine in the current study. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Control Group
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Reporting group description |
Subjects previously primed with 3 doses of Chinese OPV vaccine in the primary study and who received a dose of DTPa/Hib vaccine in the current study. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Notes [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: For a given subject and for the analysis of solicited symptom within 4 days post-vaccination, missing or non-evaluable measurements were not replaced. Therefore the analysis of the solicited symptoms included only doses with documented safety data (i.e. symptom screen completed). [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: For a given subject and for the analysis of solicited symptom within 4 days post-vaccination, missing or non-evaluable measurements were not replaced. Therefore the analysis of the solicited symptoms included only doses with documented safety data (i.e. symptom screen completed). [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: For a given subject and for the analysis of solicited symptom within 4 days post-vaccination, missing or non-evaluable measurements were not replaced. Therefore the analysis of the solicited symptoms included only doses with documented safety data (i.e. symptom screen completed). [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: For a given subject and for the analysis of solicited symptom within 4 days post-vaccination, missing or non-evaluable measurements were not replaced. Therefore the analysis of the solicited symptoms included only doses with documented safety data (i.e. symptom screen completed). [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: For a given subject and for the analysis of solicited symptom within 4 days post-vaccination, missing or non-evaluable measurements were not replaced. Therefore the analysis of the solicited symptoms included only doses with documented safety data (i.e. symptom screen completed). |
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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 |