Clinical Trial Results:
A phase IV, open-label, single-centre study to assess the long-term persistence of hepatitis A antibodies in healthy adults, primed 21 to 25 years earlier with GSK Biologicals’ hepatitis A vaccine Havrix (SB208109) in studies HAV-112 (208109/108) or HAV-123 (208109/114).

Trial information Top of page
Trial identification
Sponsor protocol code	116763
Additional study identifiers
ISRCTN number	-
US NCT number	-
WHO universal trial number (UTN)	-
Sponsors
Sponsor organisation name	GlaxoSmithKline Biologicals
Sponsor organisation address	Rue de l’Institut 89, Rixensart, Belgium, B-1330
Public contact	Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
Scientific contact	Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
Paediatric regulatory details
Is trial part of an agreed paediatric investigation plan (PIP)	No
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?	No
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?	No
Results analysis stage
Analysis stage	Final
Date of interim/final analysis	19 Nov 2014
Is this the analysis of the primary completion data?	No
Global end of trial reached?	Yes
Global end of trial date	19 Nov 2014
Was the trial ended prematurely?	Yes
General information about the trial
Main objective of the trial	To evaluate the persistence of anti-HAV antibodies in terms of seropositivity rate and geometric mean concentration (GMC), 21 to 25 years after the second vaccine dose.
Protection of trial subjects	The study was cancelled before active (see attached statement). No patient entered the study, therefore no results / data are available.
Background therapy	-
Evidence for comparator	-
Actual start date of recruitment	19 Nov 2014
Long term follow-up planned	No
Independent data monitoring committee (IDMC) involvement?	No
Population of trial subjects
Number of subjects enrolled per country
Country: Number of subjects enrolled	Belgium: 99999
Worldwide total number of subjects	99999
EEA total number of subjects	99999
Number of subjects enrolled per age group
In utero	0
Preterm newborn - gestational age < 37 wk	0
Newborns (0-27 days)	0
Infants and toddlers (28 days-23 months)	0
Children (2-11 years)	0
Adolescents (12-17 years)	0
Adults (18-64 years)	99999
From 65 to 84 years	0
85 years and over	0

Trial information Top of page

Subject disposition Top of page
Recruitment
Recruitment details	99999 is "Not applicable" value or 0 participants, the study was cancelled before active. No patient entered the study, therefore no results / data are available.
Pre-assignment
Screening details	Study cancelled before active (see attached statement)
Period 1
Period 1 title	Cancelled before active period (overall period)
Is this the baseline period?	Yes
Allocation method	Not applicable
Blinding used	Not blinded
Arms
Arm title	No-Arm
Arm description	-
Arm type	Experimental
Investigational medicinal product name	Havrix 1440 Adult
Investigational medicinal product code
Other name
Pharmaceutical forms	Suspension for injection
Routes of administration	Intramuscular use
Dosage and administration details	The product was not administered as the study was cancelled before active.
Number of subjects in period 1 No-Arm Started 99999 Completed 99999

Subject disposition Top of page

Baseline characteristics Top of page
Baseline characteristics reporting groups
Reporting group title	Cancelled before active period
Reporting group description	-
Reporting group values Cancelled before active period Total Number of subjects 99999 99999 Age categorical Units: Subjects Age continuous Units: years     arithmetic mean (standard deviation) 0 ( 0 ) - Gender categorical Units: Subjects     All 99999 99999

Baseline characteristics Top of page

End points Top of page
End points reporting groups
Reporting group title	No-Arm
Reporting group description	-

End points Top of page

Primary: No endpoint results Top of page
End point title	No endpoint results [1]
End point description
End point type	Primary
End point timeframe	The study was cancelled before active (see attached statement)
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 study was cancelled before active (see attached statement).
End point values No-Arm Number of subjects analysed 99999 Units: Subjects 99999
No statistical analyses for this end point

Primary: No endpoint results Top of page

Adverse events Top of page
Adverse events information [1]
Timeframe for reporting adverse events	The study was cancelled before active (see attached statement)
Assessment type	Systematic
Dictionary used for adverse event reporting
Dictionary name	MedDRA
Dictionary version	0
Frequency threshold for reporting non-serious adverse events: 0%
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: The study was cancelled before active (see attached statement).

Adverse events Top of page

More information Top of page
Substantial protocol amendments (globally)
Were there any global substantial amendments to the protocol? No
Interruptions (globally)
Were there any global interruptions to the trial? Yes
Date Interruption Restart date 19 Nov 2014 The study was cancelled before active (see attached statement). -
Limitations and caveats
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
None reported

More information Top of page