Clinical Trial Results:
A Multi Center, Phase IV, Randomized, Controlled, Observer Blind Study to Evaluate the Immunogenicity, Safety, and Tolerability of a Trivalent Subunit Inactivated Influenza Vaccine in Healthy Subjects Aged 50 Years and Above
Summary
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EudraCT number |
2012-003740-74 |
Trial protocol |
CZ |
Global end of trial date |
16 Dec 2013
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Results information
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Results version number |
v2(current) |
This version publication date |
29 Jul 2016
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First version publication date |
29 Nov 2014
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Other versions |
v1 (removed from public view) |
Version creation reason |
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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_22
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01867021 | ||
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 |
Lucie Černá Hlavatá, Novartis s.r.l., 420 226293041, lucie.cerna_hlavata@novartis.com
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Scientific contact |
Lucie Černá Hlavatá, Novartis s.r.l., 420 226293041, lucie.cerna_hlavata@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? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
16 Dec 2013
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
16 Dec 2013
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Global end of trial reached? |
Yes
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Global end of trial date |
16 Dec 2013
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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 demonstrate the non-inferiority of the post-vaccination (Day 22) hemagglutination inhibition (HI) geometric mean titers (GMTs) of AGRIFLU over the corresponding GMTs of the comparator vaccine for all three influenza strains, in healthy adults aged 50 years and above.
To demonstrate non-inferiority of the percentages of subjects achieving seroconversion in antibody titers at Day 22 in the AGRIFLU group over the corresponding percentages of subjects in the comparator group for all three strains, in healthy adults aged 50 years and above.
Safety Objectives
To evaluate the safety and tolerability of of AGRIFLU or comparator vaccines in healthy adults aged 50 years and above.
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Protection of trial subjects |
Novartis Vaccines or the investigator provided the ethics committee (EC) with all appropriate material,including the Informed Consent Form (ICF), according to local regulations. The EC also was asked for a written statement regarding the composition of the committee and to comply with GCP (Good Clinical Practices) and with the applicable regulatory requirement(s). The trial was not initiated until appropriate EC approval of the protocol and the ICF was obtained. In addition, all documents were submitted to other authorities in compliance with local jurisdictions. Prior to enrollment, the sponsor and the investigator exchanged written confirmation that their ethical and legal responsibilities had been observed. The EC and, if applicable, other authorities were informed of protocol amendments in accordance with local legal requirements. Appropriate reports on the progress of the study were made to the EC and the sponsor by the investigator in accordance with applicable governmental regulations and in agreement with policy established by the sponsor
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
31 May 2013
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Safety | ||
Long term follow-up duration |
36 Months | ||
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 |
Czech Republic: 785
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Country: Number of subjects enrolled |
Philippines: 500
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Country: Number of subjects enrolled |
South Africa: 1207
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Country: Number of subjects enrolled |
Thailand: 410
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Worldwide total number of subjects |
2902
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EEA total number of subjects |
785
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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) |
1441
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From 65 to 84 years |
1436
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85 years and over |
25
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Recruitment
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Recruitment details |
A total of 24 sites with 3 sites in Thailand, 4 sites in Philippines, 15 sites in South Africa and 2 sites in Czech Republic. | |||||||||||||||||||||||||||
Pre-assignment
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Screening details |
All enrolled subjects 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 |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator, Carer | |||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Agriflu | |||||||||||||||||||||||||||
Arm description |
Subjects ≥50 years of age who received one vaccination of an investigational vaccine TIV | |||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||
Investigational medicinal product name |
Trivalent Subunit Inactivated Influenza Vaccine
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Investigational medicinal product code |
V71
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Other name |
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Pharmaceutical forms |
Emulsion and suspension for emulsion for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
A single 0.5 mL dose of the study vaccine was supplied in prefilled syringes and was administered intramuscular (IM) in the deltoid muscle of (preferably) the nondominant arm.
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Arm title
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Fluvirin | |||||||||||||||||||||||||||
Arm description |
Subjects ≥50 years of age who received one vaccination of a control vaccine TIVf | |||||||||||||||||||||||||||
Arm type |
Active comparator | |||||||||||||||||||||||||||
Investigational medicinal product name |
Fluvirin
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Investigational medicinal product code |
V71
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Other name |
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Pharmaceutical forms |
Emulsion and suspension for emulsion for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
A single 0.5 mL dose of the Fluvirin was administered IM in the deltoid muscle of (preferably) the nondominant arm.
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Baseline characteristics reporting groups
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Reporting group title |
Agriflu
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Reporting group description |
Subjects ≥50 years of age who received one vaccination of an investigational vaccine TIV | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Fluvirin
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Reporting group description |
Subjects ≥50 years of age who received one vaccination of a control vaccine TIVf | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Agriflu
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Reporting group description |
Subjects ≥50 years of age who received one vaccination of an investigational vaccine TIV | ||
Reporting group title |
Fluvirin
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Reporting group description |
Subjects ≥50 years of age who received one vaccination of a control vaccine TIVf | ||
Subject analysis set title |
≥50 to ≤64 years_Agriflu_PPS1
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Subjects ≥50 to ≤64 years of age who received an investigational vaccine TIV
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Subject analysis set title |
≥50 to ≤64 years_Fluvirin_PPS1
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Subjects ≥50 to ≤64 years of age who received a control vaccine TIVf
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Subject analysis set title |
≥65 years_Agriflu_PPS1
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Subjects ≥65 years of age who received an investigational vaccine TIV
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Subject analysis set title |
≥65 years_Fluvirin_PPS1
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Subjects ≥65 years of age who received a control vaccine TIVf
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Subject analysis set title |
≥50 to ≤64 years_Agriflu_PPS2
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Subjects ≥50 to ≤64 years of age who received an investigational vaccine TIV
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Subject analysis set title |
≥50 to ≤64 years_Fluvirin_PPS2
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Subjects ≥50 to ≤64 years of age who received a control vaccine TIVf
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Subject analysis set title |
≥65 years_Agriflu_PPS2
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Subjects ≥65 years of age who received an investigational vaccine TIV
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Subject analysis set title |
≥65 years_Fluvirin_PPS2
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Subjects ≥65 years of age who received a control vaccine TIVf
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Subject analysis set title |
≥50 years_Agriflu_PPS1
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Subjects ≥50 years of age who received an investigational vaccine TIV
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Subject analysis set title |
≥50 years_Fluvirin_PPS1
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Subjects ≥50 years of age who received a control vaccine TIVf
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End point title |
1.Non-inferiority of Postvaccination Hemagglutination Inhibition (HI) Geometric Mean Titers (GMTs) of TIV Group | |||||||||||||||||||||
End point description |
Immunogenicity was measured as the hemagglutination inhibition (HI) geometric mean titers (GMTs) achieved by subjects, against each of three vaccine strains, three weeks after one vaccination of TIV (Trivalent Subunit Inactivated Influenza Vaccine) and TIVf vaccine (day 22), evaluated using HI antigen assay.
The upper limit of the two-sided 95% confidence interval (CI) on the ratio of GMTs (GMT TIVf/GMT TIV) should not exceed the non-inferiority margin of 1.5.
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End point type |
Primary
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End point timeframe |
Day 22
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Statistical analysis title |
Non-inferiority of HI GMTs of TIV vaccine over HI | |||||||||||||||||||||
Statistical analysis description |
The HI GMTs of TIV vaccine for strain A/H1N1 considered non-inferior to HI GMTs of TIVf vaccine if the upper limit of the two-sided 95% CI on the ratio of GMTs (GMT TIVf / GMT TIV) was ≤1.5
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Comparison groups |
Fluvirin v Agriflu
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Number of subjects included in analysis |
2902
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority | |||||||||||||||||||||
Method |
ANCOVA | |||||||||||||||||||||
Parameter type |
Ratios of GMTs | |||||||||||||||||||||
Point estimate |
1.85
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Confidence interval |
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level |
95% | |||||||||||||||||||||
sides |
2-sided
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lower limit |
1.66 | |||||||||||||||||||||
upper limit |
2.06 | |||||||||||||||||||||
Statistical analysis title |
Non-inferiority of HI GMTs of TIV vaccine over HI | |||||||||||||||||||||
Statistical analysis description |
The HI GMTs of TIV vaccine for strain A/H3N2 considered non-inferior to HI GMTs of TIVf vaccine if the upper limit of the two-sided 95% CI on the ratio of GMTs (GMT TIVf / GMT TIV) was ≤1.5
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Comparison groups |
Agriflu v Fluvirin
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Number of subjects included in analysis |
2902
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority | |||||||||||||||||||||
Method |
ANCOVA | |||||||||||||||||||||
Parameter type |
Ratio of GMTs | |||||||||||||||||||||
Point estimate |
1.5
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Confidence interval |
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level |
95% | |||||||||||||||||||||
sides |
2-sided
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lower limit |
1.38 | |||||||||||||||||||||
upper limit |
1.64 | |||||||||||||||||||||
Statistical analysis title |
Non-inferiority of HI GMTs of TIV vaccine over HI | |||||||||||||||||||||
Statistical analysis description |
The HI GMTs of TIV vaccine for strain B considered non-inferior to HI GMTs of TIVf vaccine if the upper limit of the two-sided 95% CI on the ratio of GMTs (GMT TIVf / GMT TIV) was ≤1.5
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Comparison groups |
Agriflu v Fluvirin
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Number of subjects included in analysis |
2902
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority | |||||||||||||||||||||
Method |
ANCOVA | |||||||||||||||||||||
Parameter type |
Ratio of GMTs | |||||||||||||||||||||
Point estimate |
1
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Confidence interval |
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level |
95% | |||||||||||||||||||||
sides |
2-sided
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lower limit |
0.93 | |||||||||||||||||||||
upper limit |
1.08 |
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End point title |
2. Non-inferiority of the Percentages of Subjects Achieving Seroconversion (SC) in Antibody Titers At Day 22 in the TIV Group | |||||||||||||||||||||
End point description |
Immunogenicity was measured as the percentages of subjects who achieved seroconversion in HI titers, against each of three vaccine strains, at three weeks after one vaccination of TIV and TIVf vaccine (day 22).
Seroconversion is defined as a prevaccination titer <10 and postvaccination HI ≥40 or as a prevaccination titer ≥10 and at minimum four-fold rise in
postvaccination antibody titer.
The upper limit of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion TIVf - SeroconversionTIV) should not exceed 10%.
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End point type |
Primary
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End point timeframe |
Day 22
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Statistical analysis title |
Non-inferiority of percentage of subjects with HI | |||||||||||||||||||||
Statistical analysis description |
Percentage of subjects with HI seroconversion of TIV vaccine for strain A/H1N1 considered non-inferior to percentage of subjects with HI seroconversion of TIVf vaccine if
the upper limit of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion TIVf - Seroconversion TIV) was ≤10%.
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Comparison groups |
Agriflu v Fluvirin
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Number of subjects included in analysis |
2902
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority | |||||||||||||||||||||
Method |
Miettinen and Nurminen | |||||||||||||||||||||
Parameter type |
Difference in seroconversion rates | |||||||||||||||||||||
Point estimate |
9
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Confidence interval |
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level |
95% | |||||||||||||||||||||
sides |
2-sided
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lower limit |
5.6 | |||||||||||||||||||||
upper limit |
11.5 | |||||||||||||||||||||
Statistical analysis title |
Non-inferiority of percentage of subjects with HI | |||||||||||||||||||||
Statistical analysis description |
Percentage of subjects with HI seroconversion of TIV vaccine for strain A/H1N1 considered non-inferior to percentage of subjects with HI seroconversion of TIVf vaccine if
the upper limit of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion TIVf - Seroconversion TIV) was ≤10%.
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Comparison groups |
Agriflu v Fluvirin
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Number of subjects included in analysis |
2902
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority | |||||||||||||||||||||
Method |
Miettinen and Nurminen | |||||||||||||||||||||
Parameter type |
Difference in seroconversion rates | |||||||||||||||||||||
Point estimate |
13
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Confidence interval |
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level |
95% | |||||||||||||||||||||
sides |
2-sided
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lower limit |
10.1 | |||||||||||||||||||||
upper limit |
16.1 | |||||||||||||||||||||
Statistical analysis title |
Non-inferiority of percentage of subjects with HI | |||||||||||||||||||||
Statistical analysis description |
Percentage of subjects with HI seroconversion of TIV vaccine for strain A/H1N1 considered non-inferior to percentage of subjects with HI seroconversion of TIVf vaccine if
the upper limit of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion TIVf - Seroconversion TIV) was ≤10%.
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Comparison groups |
Agriflu v Fluvirin
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Number of subjects included in analysis |
2902
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority | |||||||||||||||||||||
Method |
Miettinen and Nurminen | |||||||||||||||||||||
Parameter type |
Difference in seroconversion rates | |||||||||||||||||||||
Point estimate |
-1
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Confidence interval |
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level |
95% | |||||||||||||||||||||
sides |
2-sided
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lower limit |
-5 | |||||||||||||||||||||
upper limit |
2.3 |
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End point title |
3.Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains | ||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Percentage of subjects achieving HI seroconversion against each of three vaccine strains was measured three weeks after vaccination of TIV and TIVf vaccine (day 22).
Percentage of subjects who achieved HI titer ≥1:40 against each of three vaccine strains was measured three weeks after one vaccination of TIV and TIVf vaccine.
According to Center for Biologics Evaluation and Research recommendations (CBER 2007), the criterion for seroconversion is considered met if the lower limit of the two-sided 95% CI for the percentage of subjects with HI seroconversion is ≥40% (<65 years) or ≥30% (≥65 years).
As per the CBER criteria, the lower limit of the two-sided 95% CI for the percentage of subjects who achieved HI titer ≥ 1:40 should be ≥70% (<65 years) or ≥60% (≥65 years).
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End point type |
Secondary
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End point timeframe |
Day 22
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No statistical analyses for this end point |
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End point title |
4. Geometric Mean Ratio of Subjects Against Each of Three Strains | |||||||||||||||||||||||||||||||||||
End point description |
Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs against each of three vaccine strains, three weeks after vaccination of TIV and TIVf vaccine (day 22).
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End point type |
Secondary
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End point timeframe |
Day 22
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No statistical analyses for this end point |
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End point title |
5. Number of Subjects Who Reported Solicited Local and Systemic Adverse Events after One Vaccination of TIV and TIVf | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after vaccination of TIV and control.
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End point type |
Secondary
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End point timeframe |
Day 1 to 7 postvaccination
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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 |
Up to 22 days
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Adverse event reporting additional description |
Serious adverse events (SAEs) were collected from day 1 through day 22. Safety Set (Overall)-All subjects in the Exposed Set who had either postvaccination AE or
solicited AE data
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
16.1
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Reporting groups
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Reporting group title |
Agriflu
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Reporting group description |
Subjects ≥50 years of age who received one vaccination of an investigational vaccine TIV | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Fluvirin
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Reporting group description |
Subjects ≥50 years of age who received one vaccination of a control vaccine TIVf | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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? Yes | |||
Date |
Amendment |
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22 Nov 2011 |
Administrative changes updated |
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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 |