Clinical Trial Results:
A phase IV, open-label, multicentre study to assess the long-term persistence of antibodies against hepatitis B and the immunogenicity and safety of a challenge dose of hepatitis B vaccine (Engerix-B™ Kinder SKF103860) in children aged 14-15 years, previously primed and boosted in the first two years of life with four doses of GSK Biologicals’ DTPa-HBV-IPV/Hib (Infanrix™ hexa SB217744) vaccine.
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Summary
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EudraCT number |
2015-003391-74 |
Trial protocol |
DE |
Global end of trial date |
05 Jul 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
20 Dec 2017
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First version publication date |
20 Dec 2017
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Other versions |
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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 |
106794
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02798952 | ||
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 |
20 Oct 2017
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
05 Jul 2017
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Global end of trial reached? |
Yes
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Global end of trial date |
05 Jul 2017
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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 hepatitis B antigen, in terms of antibody concentrations ≥100 mIU/ml, one month after the single challenge dose of the HBV vaccine in subjects 14-15 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 |
The subjects will be observed closely for at least 30 minutes following the administration of the vaccine, with appropriate medical treatment readily available in case of anaphylaxis.
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Background therapy |
At each study visit, the investigator should question the subject’s parent(s)/LAR(s) about any medication/product taken and vaccination received by the subject. | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
23 Aug 2016
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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: 302
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Worldwide total number of subjects |
302
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EEA total number of subjects |
302
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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) |
302
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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 |
Subjects, who were previously primed and boosted with four doses of Infanrix hexa in the first two years of life, received a single challenge dose of Engerix-B Kinder. | ||||||
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 |
1 dose, intramuscular use
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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 challenge dose of Engerix-B Kinder. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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 challenge dose of Engerix-B Kinder. | ||
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End point title |
Anti-Hepatitis B surface (anti-HBs) antibody concentrations [1] | ||||||||||
End point description |
Concentrations were expressed in geometric mean concentrations (GMCs).
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End point type |
Primary
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End point timeframe |
At Day 30.
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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 | ||||||||||
End point description |
Concentrations were expressed in geometric mean concentrations (GMCs).
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End point type |
Secondary
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End point timeframe |
At Day 0
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| No statistical analyses for this end point | |||||||||||
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End point title |
Number of seropositive subjects for anti-HBs. | ||||||||||
End point description |
A seropositve subject was defined as a subject with anti-HBs antibody concentrations above the assay cut-off (≥ 6.2 mIU/ml).
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End point type |
Secondary
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End point timeframe |
At Day 0 and Day 30
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| No statistical analyses for this end point | |||||||||||
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End point title |
Number of seroprotected subjects for anti-HBs. | ||||||||||
End point description |
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations equal to or above 10 milli-International units per milliliter (mIU/ml).
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End point type |
Secondary
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End point timeframe |
At Day 0 and day 30
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| No statistical analyses for this end point | |||||||||||
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End point title |
Number of subjects with anti-HBs concentrations above the cut-off. | ||||||||||
End point description |
The cut-off of the assay was ≥ 100 mIU/mL.
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End point type |
Secondary
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End point timeframe |
At Day 0 and Day 30
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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 Hepatitis B challenge dose. | ||||||||
End point description |
Anamnestic response 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 |
At Day 30
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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 and general symptoms. | ||||||||||||||||||||
End point description |
Solicited local symptoms assessed were pain, redness and swelling at injection site. Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and fever (defined as axillary temperature ≥ 37.5°C).
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End point type |
Secondary
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End point timeframe |
Within 4 days (Day 0 - Day 3) after the 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 |
An unsolicited AE was defined as any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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End point type |
Secondary
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End point timeframe |
Within 31 days (Day 0 - Day 30) after the 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 |
An SAE was defined as any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
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End point type |
Secondary
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End point timeframe |
From Day 0 to Day 30
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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 local and general symptoms: during the 4-day (Day 0–3) follow-up period after vaccination. Unsolicited AE(s) and SAE(s): during the entire study period (Days 0-30).
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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 |
19.0
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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 Infanrix hexa in the first two years of life, received a single challenge dose of Engerix-B Kinder. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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 | |||
