Clinical Trial Results:
Evaluating the safeness of Agrippal S1 in preventing flu on Vietnamese volunteers.
Summary
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EudraCT number |
2014-005128-91 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
04 Mar 2010
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Results information
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Results version number |
v2(current) |
This version publication date |
28 Jul 2016
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First version publication date |
03 May 2015
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Other versions |
v1 (removed from public view) |
Version creation reason |
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Summary report(s) |
V71_21 CTRD 13 Apr 15 |
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 |
V71_21
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01123954 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Novartis Vaccines and Diagnostics S.r.l.
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Sponsor organisation address |
Via Fiorentina 1, Siena, Italy, 53100
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Public contact |
Posting Director, Novartis Vaccines and Diagnostics S.r.l., RegistryContactVaccinesUS@novartis.com
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Scientific contact |
Posting Director, Novartis Vaccines and Diagnostics S.r.l., RegistryContactVaccinesUS@novartis.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 Apr 2010
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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 |
04 Mar 2010
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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 evaluate the safety of a single 0.5mL dose of Agrippal S1 administered to Vietnamese volunteers.
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Protection of trial subjects |
This trial was performed with the ethical principles that have their origin in the Declaration of Helsinki, that are consistent with Good Clinical Practice (GCP) according to International Conference on Harmonisation (ICH) guidelines, the applicable regulatory requirements(s) for the country in which the study is conducted, and applicable standard operating procedures (SOPs). The benefits of the study were in proportion to the risks; the rights and welfare of the subjects were respected; the physicians conducting the trial did not find the hazards to outweigh the potential benefits.
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Background therapy |
N/A | ||
Evidence for comparator |
N/A | ||
Actual start date of recruitment |
29 Jan 2010
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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 |
Vietnam: 33
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Worldwide total number of subjects |
33
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EEA total number of subjects |
0
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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) |
1
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Adolescents (12-17 years) |
1
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Adults (18-64 years) |
31
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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 |
Subjects were enrolled at 1 center in Vietnam. | ||||||
Pre-assignment
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Screening details |
All subjects enrolled were included in the trial. | ||||||
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 |
Not applicable
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Blinding used |
Not blinded | ||||||
Blinding implementation details |
The trial was designed as a single-arm, open-label study.
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Arms
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Arm title
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Agrippal | ||||||
Arm description |
Subjects received a single 0.5mL dose of Agrippal S1. | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Trivalent influenza virus vaccine (surface antigen, inactivated, egg derived)
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Investigational medicinal product code |
Agrippal
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Other name |
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Pharmaceutical forms |
Suspension for injection in pre-filled syringe
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Routes of administration |
Intramuscular use
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Dosage and administration details |
One dose of 0.5 mL
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Baseline characteristics reporting groups
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Reporting group title |
Agrippal
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Reporting group description |
Subjects received a single 0.5mL dose of Agrippal S1. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Enrolled Set
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Subject analysis set type |
Safety analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
All enrolled subjects.
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Subject analysis set title |
Safety Set
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Subject analysis set type |
Safety analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
All enrolled subjects were included in the safety set.
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End points reporting groups
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Reporting group title |
Agrippal
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Reporting group description |
Subjects received a single 0.5mL dose of Agrippal S1. | ||
Subject analysis set title |
Enrolled Set
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
All enrolled subjects.
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Subject analysis set title |
Safety Set
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
All enrolled subjects were included in the safety set.
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End point title |
Number of subjects reporting solicited local and systemic reactions during the 7 days following one dose of Agrippal S1 [1] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 after the vaccination with of Agrippal S1. Analysis performed on the safety set.
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End point type |
Primary
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End point timeframe |
Within 30 minutes after vaccination and for 7 days after vaccination
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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: There were no statistical analysis done. |
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No statistical analyses for this end point |
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End point title |
Number of subjects reporting any unsolicited adverse events (AEs) after receiving one dose of Agrippal S1. [2] | ||||||||||||||
End point description |
Safety was assessed as the number of subjects who reported unsolicited AEs up to approximately 30 days after the vaccination with of Agrippal S1. Analysis performed on the safety set.
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End point type |
Primary
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End point timeframe |
Approximately 30 days after vaccination.
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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: There were no statistical analysis done. |
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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 |
All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; all other serious and non-serious AEs were collected for approximately 30 days after the vaccination.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
17.1
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Reporting groups
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Reporting group title |
Agrippal
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Reporting group description |
Subjects received a single 0.5mL dose of Agrippal S1. | ||||||||||||||||||||||||||||||||||||||||||
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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. | |||
The data-sets in this third-country study were manually computed. Please refer to the report submitted to the Vietnamese health authority for information (attached in the summary attachment section). |