Clinical Trial Results:
A phase IV, non-randomised, open-label, multicentre study with two parallel groups to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ combined DTPa-HBV-IPV/Hib vaccine administered as a three-dose primary vaccination course at 2, 4 and 6 months of age in healthy infants in Canada.
Summary
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EudraCT number |
2013-003428-34 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
12 Mar 2013
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Results information
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Results version number |
v1 |
This version publication date |
11 May 2016
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First version publication date |
30 May 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 |
103506
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00753649 | ||
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 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 |
28 Nov 2013
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
12 Mar 2013
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Global end of trial reached? |
Yes
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Global end of trial date |
12 Mar 2013
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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 immune response to the Hib component of GSK Biologicals’ combined DTPa-HBV-IPV/Hib preservative-free vaccine in terms of seroprotection rates one month after the three-dose primary vaccination course in “Aboriginal infants” and “Other Non-Aboriginal infants”.
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Protection of trial subjects |
All subjects were supervised after vaccination/product administration with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
23 Sep 2008
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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 |
Canada: 224
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Worldwide total number of subjects |
224
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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) |
224
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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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Infanrix Hexa Aboriginal Group | ||||||||||||||||||||||||
Arm description |
- | ||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||
Investigational medicinal product name |
Infanrix™ Hexa
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Investigational medicinal product code |
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Other name |
DTPa-HBV-IPV/Hib
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Three doses of Infanrix Hexa™ vaccine were administered by injection, intramuscularly in the right side of the tight, at 2, 4 and 6 months of age.
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Investigational medicinal product name |
Rotarix™
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Investigational medicinal product code |
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Other name |
HRV
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Pharmaceutical forms |
Oral drops
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Routes of administration |
Oral use
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Dosage and administration details |
Two doses of Rotarix™ vaccine were administered concomitantly with the first two doses of Infanrix Hexa™ vaccine. Rotarix™ was given orally at 2 and 4 months of age, according to the immunization schedule.
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Arm title
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Infanrix Hexa Non-Aboriginal Group | ||||||||||||||||||||||||
Arm description |
- | ||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||
Investigational medicinal product name |
Infanrix™ Hexa
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Investigational medicinal product code |
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Other name |
DTPa-HBV-IPV/Hib
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Three doses of Infanrix Hexa™ vaccine were administered by injection, intramuscularly in the right side of the tight, at 2, 4 and 6 months of age.
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Investigational medicinal product name |
Rotarix™
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Investigational medicinal product code |
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Other name |
HRV
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Pharmaceutical forms |
Oral drops
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Routes of administration |
Oral use
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Dosage and administration details |
Two doses of Rotarix™ vaccine were administered concomitantly with the first two doses of Infanrix Hexa™ vaccine. Rotarix™ was given orally at 2 and 4 months of age, according to the immunization schedule.
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Baseline characteristics reporting groups
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Reporting group title |
Infanrix Hexa Aboriginal Group
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Infanrix Hexa Non-Aboriginal Group
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Infanrix Hexa Aboriginal Group
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Reporting group description |
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Reporting group title |
Infanrix Hexa Non-Aboriginal Group
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Reporting group description |
- |
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End point title |
Number of seroprotected subjects against Polyribosyl-ribitol phosphate (anti-PRP) [1] | ||||||||||||
End point description |
A seroprotected subject was a subject whose anti-PRP antibody concentration was ≥0.15 µg/mL.
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End point type |
Primary
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End point timeframe |
One month after (POST) Dose 3.
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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 with anti-Polyribosyl-ribitol phosphate (anti-PRP) antibodies with concentrations ≥1µg/mL | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
One month after (POST) Dose 3.
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No statistical analyses for this end point |
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End point title |
Anti-PRP antibody concentrations | |||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
One month after (POST) Dose 3.
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No statistical analyses for this end point |
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End point title |
Number of seroprotected subjects against Hepatitis B (anti-HBs), with anti-HBs antibody concentrations ≥ 10 μg/mL | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
One month after (POST) Dose 3.
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No statistical analyses for this end point |
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End point title |
Number of subjects with Anti-HBs antibody concentrations ≥100 mIU/mL | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
One month after (POST) Dose 3.
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No statistical analyses for this end point |
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End point title |
Anti-HBs antibody concentrations | |||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
One month after (POST) Dose 3.
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No statistical analyses for this end point |
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End point title |
Number of subjects with unsolicited adverse events (AEs) | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
During the 31 day (Days 0-30) post vaccination
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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 |
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End point type |
Secondary
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End point timeframe |
During the entire study period
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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 |
Unsolicited AEs during the 31-day post-vaccination period, SAEs during the entire period
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
16.1
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Reporting groups
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Reporting group title |
Infanrix Hexa Aboriginal Group
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Reporting group description |
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Reporting group title |
Infanrix Hexa Non-Aboriginal Group
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Reporting group description |
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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? Yes | |||
Date |
Amendment |
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24 Jun 2010 |
Amendment 2
The protocol was originally designed for sites in British Columbia (BC) and therefore the vaccines that the subject may receive outside of the study were recommended according to the BC vaccination schedule. New sites were selected in provinces where the recommended schedule for vaccine co-administration is different from BC, therefore the protocol is being amended to allow vaccine coadministration according to the provincial schedule rather than the BC schedules.
• Some formatting errors have been corrected in the protocol.
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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 |