Clinical Trial Results:
Persistence of hepatitis B antibodies, immunogenicity and safety of GSK Biologicals’ hepatitis B vaccine EngerixTM-B Kinder (SKF103860) challenge dose in adolescents vaccinated with four doses of InfanrixTM hexa (SB217744) during infancy.
Summary
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EudraCT number |
2013-002821-41 |
Trial protocol |
DE |
Global end of trial date |
23 Sep 2014
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Results information
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Results version number |
v2(current) |
This version publication date |
20 Nov 2018
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First version publication date |
10 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 |
106793
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02052661 | ||
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, 44 2089904466, GSKClinicalSupportHD@gsk.com
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Scientific contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 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? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
28 May 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
23 Sep 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
23 Sep 2014
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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, in terms of subjects with antibody concentrations >= 100 mIU/ml, to a single challenge dose of HBV vaccine (Engerix-B Kinder) in subjects 12–13 years of age, previously vaccinated with four doses of Infanrix hexa in the first two 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 |
13 Jan 2014
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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: 300
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Worldwide total number of subjects |
300
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EEA total number of subjects |
300
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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) |
0
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Adolescents (12-17 years) |
300
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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 |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||
Arms
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Arm title
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Engerix™-B Kinder Group | ||||||
Arm description |
Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm. | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Engerix™-B Kinder
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Investigational medicinal product code |
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Other name |
HBV vaccine, GlaxoSmithKline (GSK) Biologicals’ recombinant hepatitis B vaccine
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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 HBV vaccine, administered intramuscularly into the deltoid of the non-dominant 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 |
Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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 |
Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm. |
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End point title |
Anti-HBs immune response. [1] | ||||||||
End point description |
Anti-HBs immune response was defined as the number of subjects with Anti-HBs antibody concentrations ≥ 100 mIU/ml.
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End point type |
Primary
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End point timeframe |
One month after the single challenge dose of Engerix™-B Kinder vaccine (Month 1)
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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 |
Anti-HBs antibody concentrations at 12-13 years of age, after previous vaccination with DTPa-HBV-IPV/Hib. | ||||||||||||
End point description |
Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of 6.2 mIU/ml.
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End point type |
Secondary
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End point timeframe |
Before (PRE) and 1 month after (POST) the single challenge dose of Engerix™-B Kinder vaccine.
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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 ≥ 6.2 mIU/ml, ≥ 10 mIU/ml, 10 to < 100 mIU/ml and ≥ 100 mIU/ml | ||||||||||||||
End point description |
A seropositive subject was defined as a subject with anti-HBs antibody concentrations ≥ 6.2 milli-international units per milliliter (mIU/ml). A seroprotected subjects was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/ml.
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End point type |
Secondary
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End point timeframe |
Before the single challenge dose of Engerix™-B Kinder vaccine.
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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 ≥ 6.2 mIU/ml and ≥ 10 mIU/ml | ||||||||||
End point description |
A seropositive subject was defined as a subject with anti-HBs antibody concentrations ≥ 6.2 mIU/ml. A seroprotected subjects was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/ml.
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End point type |
Secondary
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End point timeframe |
1 month after the single challenge dose of Engerix™-B Kinder vaccine.
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No statistical analyses for this end point |
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End point title |
Number of subjects with an anamnestic response to the single challenge dose of HBV vaccine. | ||||||||
End point description |
The amnestic response to the challenge dose was defined as: for initially seronegative subjects, antibody concentration ≥ 10mIU/mL; for initially seropositive subjects, antibody concentration at least four times the pre-challenge antibody concentration.
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End point type |
Secondary
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End point timeframe |
One month after the single challenge dose of Engerix™-B Kinder vaccine.
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No statistical analyses for this end point |
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End point title |
Number of subjects with any solicited local symptoms. | ||||||||||||
End point description |
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
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End point type |
Secondary
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End point timeframe |
During the 4-day (Day 0–3) follow-up period after the single challenge dose of Engerix™-B Kinder vaccine.
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No statistical analyses for this end point |
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End point title |
Number of subjects with any solicited general symptoms. | ||||||||||||||
End point description |
Assessed solicited general symptoms were fatigue, gastrointestinal, headache and temperature [defined as axillary temperature equal to oe above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.
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End point type |
Secondary
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End point timeframe |
During the 4-day (Day 0–3) follow-up period after the single challenge dose of Engerix™-B Kinder vaccine.
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No statistical analyses for this end point |
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End point title |
Number of subjects with any unsolicited adverse events (AEs). | ||||||||
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 and 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
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End point type |
Secondary
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End point timeframe |
During the 31-day (Day 0–30) follow-up period after the single challenge dose of Engerix™-B Kinder vaccine.
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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 result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
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End point type |
Secondary
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End point timeframe |
From Month 0 to Month 1
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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 the 4-day (Day 0–3) follow-up period after vaccination
Unsolicited AEs: during the 31-day (Day 0–30) follow-up period after vaccination
SAEs: During the entire study.
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Adverse event reporting additional description |
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
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Assessment type |
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 |
Engerix™-B Kinder Group
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Reporting group description |
Subjects who were previously primed and boosted with four doses of DTPa-HBV-IPV/Hib in the first two years of life, received a single dose of HBV vaccine. | ||||||||||||||||||||||||||||||||||||||||||||
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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. | |||
None reported |