Clinical Trial Results:
An open, phase IV, single-group multicentre study to assess the long-term persistence of antibodies against hepatitis B and the immune response to a hepatitis B vaccine challenge in children at 4-5 years of age, previously primed and boosted in the first two years of life with GlaxoSmithKline (GSK) Biologicals’ DTPa-HBV-IPV/Hib vaccine.
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Summary
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EudraCT number |
2006-000556-41 |
Trial protocol |
DE |
Global end of trial date |
14 May 2007
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Results information
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Results version number |
v2(current) |
This version publication date |
31 Jul 2016
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First version publication date |
06 Jun 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 |
106789
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00411697 | ||
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 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 |
11 Jan 2008
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
14 May 2007
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Global end of trial reached? |
Yes
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Global end of trial date |
14 May 2007
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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 anti-HBs antibody response to a challenge dose of HBV vaccine in subjects at 4-5 years of age, previously vaccinated with 4 doses of DTPa-HBV-IPV/Hib vaccine in the first 2 years of life.
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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 |
19 Dec 2006
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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 |
Germany: 301
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Worldwide total number of subjects |
301
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EEA total number of subjects |
301
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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) |
0
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Children (2-11 years) |
301
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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 study (overall period)
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Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||
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Arms
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Arm title
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Engerix-B Kinder Group | ||||||||||
Arm description |
- | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
Engerix™-B Kinder
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects received a single dose of hepatitis B vaccine injected intramuscularly into the deltoid region of the left arm.
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Baseline characteristics reporting groups
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Reporting group title |
Engerix-B Kinder Group
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Engerix-B Kinder Group
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Reporting group description |
- | ||
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End point title |
Number of subjects with anti-hepatitis B surface antigen (anti-HBs) antibody concentrations ≥ 100 mIU/mL [1] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
1 Month post 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. |
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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 ≥ 10 mIU/mL | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
1 Month post vaccination
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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 |
1 Month post vaccination
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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 ≥ 10 mIU/mL | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Before vaccination
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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 ≥ 10 mIU/mL and < 100 mIU/mL | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Before vaccination
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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 |
Before vaccination
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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 |
Before vaccination
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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 |
Within Day 0-30 following 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 [1]
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Timeframe for reporting adverse events |
SAEs during the entire study period. Unsolicited adverse events day 0-30 following vaccination.
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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 |
9.1
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Reporting groups
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Reporting group title |
Engerix-B Kinder 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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| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: Reported non-serious adverse events are under the 5% frequency threshold. |
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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 | |||
