Clinical Trial Results:
A phase IV, open, randomized, controlled study to demonstrate the non-inferiority of co-administration of GSK Biologicals’ live attenuated measles-mumps-rubella-varicella vaccine and Baxter’s Neisseria meningitidis C conjugate vaccine versus separate administration of each of the vaccines in healthy children aged 12 through 23 months
Summary
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EudraCT number |
2008-003318-81 |
Trial protocol |
DE |
Global end of trial date |
27 Nov 2012
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Results information
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Results version number |
v1(current) |
This version publication date |
30 Jan 2019
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First version publication date |
30 Jan 2019
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Other versions |
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Summary report(s) |
Cancelled before Active Statement |
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 |
111846
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
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 Disclosure Advisor, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
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Scientific contact |
Clinical Disclosure Advisor, 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? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
27 Nov 2012
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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 Nov 2012
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
To demonstrate the non-inferiority in terms of immunogenicity of the first dose of MMRV vaccine co administered with MenC conjugate vaccine compared to the first dose of MMRV vaccine alone with respect to anti-measles, anti-mumps, anti-rubella, and anti-varicella seroconversion rates.
To demonstrate the non-inferiority of MenC conjugate vaccine co administered with MMRV compared to MenC conjugate vaccine alone in terms of serum bactericidal antibodies against Neisseria meningitidis serogroup C
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Protection of trial subjects |
The study was cancelled before active (see attached statement). No patient entered the study, therefore no results/data are available.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
27 Nov 2012
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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 |
Poland: 50000
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Country: Number of subjects enrolled |
Germany: 49999
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Worldwide total number of subjects |
99999
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EEA total number of subjects |
99999
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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) |
99999
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Children (2-11 years) |
0
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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 |
99999 is "Not Applicable" value or '0' participants. The study was cancelled before active (see attached statement). No patient entered the study, therefore no results/data are available. | ||||||||||
Pre-assignment
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Screening details |
The study was cancelled before active (see attached statement). | ||||||||||
Period 1
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Period 1 title |
Cancelled before active period (overall period)
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Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||
Arms
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Arm title
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No-Arm | ||||||||||
Arm description |
- | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
Priorix-Tetra
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and solution for solution for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
The product was not administered as the study was cancelled before active.
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End points reporting groups
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Reporting group title |
No-Arm
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Reporting group description |
- |
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End point title |
No end point results [1] | ||||||
End point description |
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End point type |
Primary
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End point timeframe |
The study was cancelled before active (see attached statement).
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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 study was cancelled before active (see attached statement). |
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
The study was cancelled before active (see attached statement).
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
15.1
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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). |
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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? Yes | |||||||
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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 |