Clinical Trial Results:
An open, phase IV, multicentre study to assess the long-term persistence of antibodies against hepatitis B and the immune response to a hepatitis B vaccine challenge in healthy children 4-6 years old, previously vaccinated with 4 doses of GlaxoSmithKline (GSK) Biologicals’ DTPa-HBV-IPV/Hib vaccine, in clinical trials conducted by GSK Biologicals.
Summary
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EudraCT number |
2006-000553-22 |
Trial protocol |
DE |
Global end of trial date |
27 Apr 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 |
10 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 |
106745
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00335881 | ||
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 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 |
09 May 2007
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
27 Apr 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 aged 4-6 years, previously primed and boosted with 4 doses of Infanrix hexa in the first two years of life.
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Protection of trial subjects |
As with all injectable vaccines, appropriate medical treatment was always readily available in case of anaphylactic reactions following the administration of the vaccine.
For this reason, the vaccine remained under medical supervision for 30 minutes after vaccination.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
02 Jun 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: 203
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Worldwide total number of subjects |
203
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EEA total number of subjects |
203
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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) |
203
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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 |
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 |
- | ||||||||||||
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 previously vaccinated with 4 doses of Infanrix hexa™ vaccine in the first 2 years of life received a dose of Engerix™-B Kinder.
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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-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 after challenge dose of Engerix™-B Kinder 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 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 after 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 |
Anti-HBs antibody concentrations | ||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
1 month after 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 above or equal the set cut-off values | ||||||||||
End point description |
The cut-off values assessed were ≥ 10 mIU/mL and ≥ 100 mIU/mL.
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End point type |
Secondary
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End point timeframe |
Before 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 |
Anti-HBs antibody concentrations | ||||||||||
End point description |
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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 subjects with anti-diphtheria (anti-D) and anti –tetanus (anti-T) antibody concentrations ≥ 0.1 IU/mL | ||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Before 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-polyribosyl ribitol phosphate (anti-PRP) antibody concentration ≥ 0.15 µg/mL and ≥ 1 µg/mL | ||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Before 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-poliovirus types 1, 2 and 3 antibody titres ≥ 8. | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Before 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-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibody concentration ≥5 EL.U/mL. | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Before 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 solicited local symptoms | ||||||||||||
End point description |
The solicited local symptoms assessed were pain, redness and swelling.
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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 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 solicited general symptoms | ||||||||||||||
End point description |
The solicited general symptoms assessed were drowsiness, fever (defined as axillary temperature >37.5C), irritability and loss of appetite.
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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 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 unsolicited adverse events (AEs). | ||||||||
End point description |
An unsolicited AE was any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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.
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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 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 |
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End point type |
Secondary
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End point timeframe |
During the entire study period (from Day 0 to Day 30).
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No statistical analyses for this end point |
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End point title |
Anti-D and anti-T antibody concentrations. | ||||||||||||
End point description |
Concentrations were expressed as geometric mean concentrations (GMCs) in IU/mL.
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End point type |
Secondary
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End point timeframe |
Before 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 |
Anti-PRP antibody concentration. | ||||||||||
End point description |
Concentrations were expressed as geometric mean concentrations (GMCs) in µg/mL.
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End point type |
Secondary
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End point timeframe |
Before 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 |
Anti-PT, anti-FHA and anti-PRN antibody concentrations. | ||||||||||||||
End point description |
Concentrations were expressed as geometric mean concentrations (GMCs) in EL.U/mL.
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End point type |
Secondary
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End point timeframe |
Before 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 |
Anti-poliovirus types 1, 2 & 3 antibody titres. | ||||||||||||||
End point description |
Titres (anti-polio) were expressed as geometric mean titres (GMTs).
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End point type |
Secondary
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End point timeframe |
Before challenge dose of Engerix™-B Kinder 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 |
Solicited symptoms: 4-day follow-up period after vaccination (Day 0 - Day 3); Unsolicited AEs: 31-day follow-up period after vaccination (Day 0 - Day 30); SAEs: during the entire study period.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||
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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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 |