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临床试验Nct页
Clinical Trial Results:
An open, randomized, controlled, phase II study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals’ 11-valent pneumococcal conjugate vaccine, when administered intramuscularly as a 3, 5, 12 month vaccination schedule, as part of a staggered vaccination schedule
Summary | |
EudraCT number | 2004-001823-39 |
Trial protocol | SE |
Global end of trial date | 27 Nov 2012 |
Results information | |
Results version number | v1(current) |
This version publication date | 22 Dec 2018 |
First version publication date | 22 Dec 2018 |
Other versions | |
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 | |||
Sponsor protocol code | 103502 | ||
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, 044 2089-904466, GSKClinicalSupportHD@gsk.com | ||
Scientific contact | Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, 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? | Yes | ||
Results analysis stage | |||
Analysis stage | Final | ||
Date of interim/final analysis | 27 Nov 2012 | ||
Is this the analysis of the primary completion data? | No | ||
Global end of trial reached? | Yes | ||
Global end of trial date | 27 Nov 2012 | ||
Was the trial ended prematurely? | Yes | ||
General information about the trial | |||
Main objective of the trial | To assess the immune response post-dose 2 elicited by GSK Biologicals’ candidate 11Pn-PD-DiT vaccine administered according to a 3, 5, 12 month vaccination schedule as part of a staggered vaccination schedule with co-administration of Infanrix™ penta and GSK Biologicals’ candidate HibMenC-TT vaccine at 2, 4 months of age. | ||
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 | 01 Nov 2004 | ||
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 | Sweden: 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 | 0 | ||
Newborns (0-27 days) | 0 | ||
Infants and toddlers (28 days-23 months) | 99999 | ||
Children (2-11 years) | 0 | ||
Adolescents (12-17 years) | 0 | ||
Adults (18-64 years) | 0 | ||
From 65 to 84 years | 0 | ||
85 years and over | 0 |
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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 | GSK Biologicals’ 11-valent Pn-PD-DiT vaccine | ||||||||||
Investigational medicinal product code | |||||||||||
Other name | |||||||||||
Pharmaceutical forms | Solution for suspension for injection | ||||||||||
Routes of administration | Intramuscular use | ||||||||||
Dosage and administration details | The product was not administered as the study was cancelled before active | ||||||||||
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End points reporting groups | |||
Reporting group title | No-Arm | ||
Reporting group description | - |
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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). | |||||||
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No statistical analyses for this end point |
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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 | 8.0 | ||
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). |
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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 | |||||||
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Limitations and caveats | |||||||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||||||
None reported |