Clinical Trial Results:
Randomized, comparative and prospective clinical trial evaluating efficacy and safety of a dose of seasonal flu vaccine compared to two doses of vaccine for prevention of influenza in solid organ transplant recipients
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Summary
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EudraCT number |
2011-003243-21 |
Trial protocol |
ES |
Global end of trial date |
28 Jul 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
03 Apr 2021
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First version publication date |
03 Apr 2021
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Other versions |
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Summary report(s) |
final report of results |
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 |
TRANSGRIPE 1-2
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
NA: NA | ||
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Sponsors
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Sponsor organisation name |
Fundación Pública Andaluza Progreso y Salud
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Sponsor organisation address |
Parque Científico y Tecnológico Cartuja, Avda. Américo Vespucio, 15. Edificio S-2. 41092 Sevilla, Seville, Spain, 41092
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Public contact |
Marta Reboredo Ares, Fundación Pública Andaluza Progreso y Salud, 34 955040450, gestionensayosclinicos.fps@juntadeandalucia.es
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Scientific contact |
Marta Reboredo Ares, Fundación Pública Andaluza Progreso y Salud, 34 955040450, gestionensayosclinicos.fps@juntadeandalucia.es
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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? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
28 Jul 2016
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
28 Jul 2016
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Global end of trial reached? |
Yes
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Global end of trial date |
28 Jul 2016
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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 study whether two doses of flu vaccine work better than single dose in transplant recipiens
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Protection of trial subjects |
The trial will be carried out in accordance with the principles of the Declaration of Helsinki (Annex 7), and according to the legal regulations in force (Royal Decree 223/2004), and will not start until the approval of the CEIC of reference, the conformity of the Directors of the Institutions, and the authorisation of the Spanish Agency of Medicines and Health Products have been obtained.
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Background therapy |
- | ||
Evidence for comparator |
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Actual start date of recruitment |
18 Sep 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 |
Spain: 499
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Worldwide total number of subjects |
499
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EEA total number of subjects |
499
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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) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
499
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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 |
The patient must meet all of the following criteria: 1. solid organ transplant recipient (hepatic, renal, cardiac, or pulmonary). 2. Age greater than or equal to 16 years. 3. More than 30 days post-transplant. 4. Negative pregnancy test in the case of women of childbearing age. 5. Patient must give written consent | |||||||||
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Pre-assignment
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Screening details |
The patient must meet all of the following criteria: 1. solid organ transplant recipient (hepatic, renal, cardiac, or pulmonary). 2. Age greater than or equal to 16 years. 3. More than 30 days post-transplant. 4. Negative pregnancy test in the case of women of childbearing age. 5. Patient must give written consent | |||||||||
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Period 1
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Period 1 title |
Recruitment and follow-up
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Control | |||||||||
Arm description |
- | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Standard seasonal influenza vaccination
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
0,5 ml Standard seasonal influenza vaccination. Immunisation should be carried out by intramuscular or deep subcutaneous injection.
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Arm title
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Experimental | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Seasonal influenza vaccination
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
0,5 ml Seasonal influenza vaccination boosted by a second dose of vaccine 5 weeks after first dose. Immunisation should be carried out by intramuscular or deep subcutaneous injection.
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Period 2
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Period 2 title |
Data analysis
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Is this the baseline period? |
No | |||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Control | |||||||||
Arm description |
- | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Standard seasonal influenza vaccination
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
0,5 ml Standard seasonal influenza vaccination. Immunisation should be carried out by intramuscular or deep subcutaneous injection.
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Arm title
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Experimental | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Seasonal influenza vaccination
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
0,5 ml Seasonal influenza vaccination boosted by a second dose of vaccine 5 weeks after first dose. Immunisation should be carried out by intramuscular or deep subcutaneous injection.
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Baseline characteristics reporting groups
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Reporting group title |
Recruitment and follow-up
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Reporting group description |
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End points reporting groups
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Reporting group title |
Control
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Reporting group description |
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Reporting group title |
Experimental
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Reporting group description |
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Reporting group title |
Control
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Reporting group description |
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Reporting group title |
Experimental
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Reporting group description |
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End point title |
Seroprotection rate at 10 weeks [1] | |||||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
At 10 weeks
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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: Not all the data required in the section are available. However, the final results report is attached, where the statistical analysis carried out is detailed. |
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| No statistical analyses for this end point | ||||||||||||||||||||||
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End point title |
Seroconversion rate [2] | |||||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
During the study
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| Notes [2] - 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: Not all the data required in the section are available. However, the final results report is attached, where the statistical analysis carried out is detailed. |
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| No statistical analyses for this end point | ||||||||||||||||||||||
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End point title |
Seroprotection rate to at least one, two or all three vaccine antigens [3] | ||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
During the study
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| Notes [3] - 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: Not all the data required in the section are available. However, the final results report is attached, where the statistical analysis carried out is detailed. |
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
GMT tittle [4] | |||||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
During the study
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| Notes [4] - 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: Not all the data required in the section are available. However, the final results report is attached, where the statistical analysis carried out is detailed. |
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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 |
During the study
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
14.1
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Reporting groups
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Reporting group title |
Control
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Reporting group description |
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Reporting group title |
Experimental
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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: There were 184 mild and 95 moderate adverse events. Not all the required information is available, although it should be noted that these adverse events are all listed in the product data sheet of the investigational product. |
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| Frequency threshold for reporting non-serious adverse events: 4% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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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05 Mar 2012 |
Summary of changes:
- Extension of selection criteria to pulmonary patients.
- Modification of inclusion and follow-up schedules (from 2011 to 2012).
- Change of medicine: seasonal vaccine 2012-2013.
- Expansion of centres: Ramón y Cajal Hospital, Madrid; Gregorio Marañon Hospital, Madrid; Hospital 12 Marañon, Madrid; Hospital 12 de Octubre, Madrid; Hospital Clinic, Barcelona; Hospital Universitario Bellvitge, Barcelona; Hospital Vall d'Hebron, Barcelona; Hospital de Cruces, Bilbao; Hospital Universitario La Fe, Valencia.
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04 May 2012 |
Summary of changes:
- Inclusion of new secondary objectives associated with the performance of a genetic sub-study.
- New follow-up visit in arm B patients 15 weeks after the first vaccine dose (10 weeks after re-vaccination).
- Changes in the randomisation procedure (by blocks, stratified by centre, type of transplant and time since transplant). |
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01 Jul 2012 |
Summary of changes:
- Inclusion of new secondary objectives associated with the performance of an immunological sub-study.
- Extension of centres: Virgen Macarena University Hospital, Seville; Marqués de Valdecilla University Hospital, Santander. |
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05 Oct 2012 |
Summary of changes:
- New follow-up visit in patients in arm A at 15 weeks after the first vaccine dose.
- Extension of the recruitment period (until 14 December 2012).
- Removal of the requirement for quarterly telephone follow-up. |
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09 Nov 2013 |
Summary of changes:
- Expansion of the sample size by 10% (from 462 to 508 patients) to make up for loss to follow-up. |
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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 | |||
