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 (HBV) vaccine challenge in children aged 7-8 years of age and previously vaccinated in infancy with GSK Biologicals’ HBV vaccine (Engerix™-B).
Summary
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EudraCT number |
2007-002221-76 |
Trial protocol |
DE |
Global end of trial date |
31 Dec 2007
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Results information
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Results version number |
v2(current) |
This version publication date |
12 Mar 2021
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First version publication date |
04 Dec 2014
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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 |
110474
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00519649 | ||
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, 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 |
31 Dec 2007
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
31 Dec 2007
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Global end of trial reached? |
Yes
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Global end of trial date |
31 Dec 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 (Engerix-B Kinder) in subjects, 7-8 years of age, previously vaccinated with three doses of Engerix-B in infancy.
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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 the vaccine.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
31 Aug 2007
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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 |
- | ||||||||||
Pre-assignment
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Screening details |
One additional subject, enrolled but not vaccinated, was not included in the number of subjects under "STARTED" | ||||||||||
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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Group Engerix | ||||||||||
Arm description |
Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine) | ||||||||||
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 |
Suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)
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Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: One additional subject, enrolled but not vaccinated, was not included in the number of subjects under "STARTED" |
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Baseline characteristics reporting groups
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Reporting group title |
Overall Study
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Group Engerix
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Reporting group description |
Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine) |
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End point title |
Number of participants with anti-hepatitis B surface antigen (HBs) antibody concentrations above the cut-off value [1] | ||||||||
End point description |
Anti-HBs antibody cut-off value assessed was 100 milli-international unit per milliliter (mIU/mL)
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End point type |
Primary
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End point timeframe |
One month after the challenge dose of HBV vaccine
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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 participants with Anti-HBs antibody concentrations above the cut-off value | ||||||||||||
End point description |
Anti-HBs antibody cut-off values assessed include 3.3, 10 and 100 mIU/mL
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End point type |
Secondary
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End point timeframe |
Before challenge dose of HBV vaccine
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No statistical analyses for this end point |
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End point title |
Number of Participants reporting Solicited Local Symptoms | ||||||||||||
End point description |
Solicited local symptoms assessed include pain, redness and swelling
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End point type |
Secondary
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End point timeframe |
During the 4-day follow-up period after the challenge dose of HBV vaccine.
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No statistical analyses for this end point |
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End point title |
Number of Participants reporting Solicited General Symptoms | ||||||||||||||
End point description |
Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms, and headache
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End point type |
Secondary
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End point timeframe |
During the 4-day follow-up period after the challenge dose of HBV vaccine.
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No statistical analyses for this end point |
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End point title |
Number of Participants reporting Unsolicited adverse events | ||||||||
End point description |
An Adverse Event is 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.
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End point type |
Secondary
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End point timeframe |
During the 31-day follow-up period after the challenge dose of HBV vaccine.
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No statistical analyses for this end point |
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End point title |
Number of Participants reporting serious adverse events (SAE) | ||||||||
End point description |
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
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End point type |
Secondary
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End point timeframe |
After the challenge dose of HBV vaccine.
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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 and Unsolicited Adverse events: During the 31-day follow-up period after HBV challenge dose. Solicited local and general symptoms: During the 4-day follow-up period after the HBV challenge dose.
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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 |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
11.0
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Reporting groups
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Reporting group title |
Group Engerix
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Reporting group description |
Subjects received a single challenge dose of Engerix™ (hepatitis-B [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? Yes | |||
Date |
Amendment |
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11 Dec 2007 |
Protocol Amendment 2
This amendment is being prepared to change the assay cut-off that that was defined as 10 mIU/ml in the original protocol to 3.3 mIU/ml. Additionally the definition of immune memory has also been included to maintain uniformity with other adult studies. |
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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 |