Clinical Trial Results:
Effect of High-Dose Quadrivalent Influenza Vaccine (Efluelda®) versus Standard-Dose (QIV-SD), in subjects 65 years of age and older on innate immunity, including gene expression.
|
Summary
|
|
EudraCT number |
2021-004573-32 |
Trial protocol |
FR |
Global end of trial date |
14 Feb 2023
|
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
19 Aug 2023
|
First version publication date |
19 Aug 2023
|
Other versions |
|
Summary report(s) |
INFLUOMICS_abstract_CSR RIPH1_V1.0_20230517 |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
|
Trial identification
|
|||
Sponsor protocol code |
21-05
|
||
|
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
NCT05154383 | ||
WHO universal trial number (UTN) |
- | ||
|
Sponsors
|
|||
Sponsor organisation name |
Centre Hospitalier Annecy Genevois
|
||
Sponsor organisation address |
1 avenue de l'hôpital, Epagny Metz-Tessy, France, 74370
|
||
Public contact |
DRCI - Marion GHIDI, Centre Hospitalier Annecy Genevois, 033 450637031, mghidi@ch-annecygenevois.fr
|
||
Scientific contact |
DRCI - Marion GHIDI, Centre Hospitalier Annecy Genevois, 033 450637031, mghidi@ch-annecygenevois.fr
|
||
|
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? |
No
|
||
|
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
17 Apr 2023
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
21 Jul 2022
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
14 Feb 2023
|
||
Was the trial ended prematurely? |
No
|
||
|
General information about the trial
|
|||
Main objective of the trial |
To evaluate the effect of QIV-HD and QIV-SD vaccines in subjects 65 years of age and older on:
- the early systemic innate immune response through transcriptomic analysis i.e. innate gene signature including interferon signaling pathways,
- innate cells including antigen presenting and inflammatory cells,
- gene signature associate with adaptive immune response before and after the influenza vaccination,
- humoral immunity i.e. HI titers, at different time points.
|
||
Protection of trial subjects |
The study was performed in compliance with the requirements of the French Agency for the Safety of Health Products (Agence Nationale de la Sécurité du Médicament et des Produits de Santé - ANSM).
The study gained initial full regulatory approval from the 2021/10/05, CHANGE was issued with the following EudraCT number 2021-004573-32. First protocol amendment was approved by the regulatory approval on 2022/01/24.
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
15 Nov 2021
|
||
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 |
France: 59
|
||
Worldwide total number of subjects |
59
|
||
EEA total number of subjects |
59
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
0
|
||
From 65 to 84 years |
59
|
||
85 years and over |
0
|
||
|
||||||||||
|
Recruitment
|
||||||||||
Recruitment details |
Number of patients planned: 60 evaluable subjects (volunteers). Number of patients randomized and analyzed: 59 (one was excluded before randomization because diagnosed with an active high-grade lymphoma, which is corresponding to a non-inclusion criterion). 28 subjects received QIV-SD vaccine and 31 subjects received QIV-HD vaccine. | |||||||||
|
Pre-assignment
|
||||||||||
Screening details |
Inclusion criteria : - Aged 65 years or older, the day of inclusion Non-inclusion criteria : - Any vaccine injection (including for COVID-19) in the 4 weeks preceding study inclusion - Plan to receive any vaccine (including for COVID-19) in the 24 hours following study inclusion - Already vaccinated against influenza for 2021-2022 season | |||||||||
|
Period 1
|
||||||||||
Period 1 title |
Visit 1: 7 days before vaccination visit
|
|||||||||
Is this the baseline period? |
No | |||||||||
Allocation method |
Randomised - controlled
|
|||||||||
Blinding used |
Not blinded | |||||||||
|
Arms
|
||||||||||
Are arms mutually exclusive |
Yes
|
|||||||||
|
Arm title
|
QIV-HD | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Efluelda
|
|||||||||
Investigational medicinal product code |
||||||||||
Other name |
||||||||||
Pharmaceutical forms |
Suspension for injection in pre-filled syringe
|
|||||||||
Routes of administration |
Injection , Intramuscular use
|
|||||||||
Dosage and administration details |
Dose: Each 0.7mL dose contains 60 μg hemagglutinin (HA) of each influenza strain. Strains were determined based on World Health Organization (WHO) and European Union (EU) recommendations for the 2021-2022 Northern Hemisphere (NH) influenza season.
Injected into the upper arm (deltoid area).
|
|||||||||
|
Arm title
|
QIV-SD | |||||||||
Arm description |
- | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
InfluvacTetra
|
|||||||||
Investigational medicinal product code |
||||||||||
Other name |
||||||||||
Pharmaceutical forms |
Suspension for injection in pre-filled syringe
|
|||||||||
Routes of administration |
Intramuscular use, Injection
|
|||||||||
Dosage and administration details |
Each 0.5mL dose contains 15 μg hemagglutinin (HA) of each influenza strain. Strains were determined based on World Health Organization (WHO) and European Union (EU) recommendations for the 2021-2022 Northern Hemisphere (NH) influenza season.
Injected into the upper arm (deltoid area).
|
|||||||||
|
||||||||||
|
Period 2
|
||||||||||
Period 2 title |
Visit 2: vaccination visit (day 0)
|
|||||||||
Is this the baseline period? |
Yes [1] | |||||||||
Allocation method |
Randomised - controlled
|
|||||||||
Blinding used |
Not blinded | |||||||||
|
Arms
|
||||||||||
Are arms mutually exclusive |
Yes
|
|||||||||
|
Arm title
|
QIV-HD | |||||||||
Arm description |
Subjects who receive the Sanofi Pasteur Quadrivalent Influenza Vaccine High-Dose Quadrivalent vaccine. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Efluelda
|
|||||||||
Investigational medicinal product code |
||||||||||
Other name |
||||||||||
Pharmaceutical forms |
Suspension for injection in pre-filled syringe
|
|||||||||
Routes of administration |
Injection , Intramuscular use
|
|||||||||
Dosage and administration details |
Dose: Each 0.7mL dose contains 60 μg hemagglutinin (HA) of each influenza strain. Strains were determined based on World Health Organization (WHO) and European Union (EU) recommendations for the 2021-2022 Northern Hemisphere (NH) influenza season.
Injected into the upper arm (deltoid area).
|
|||||||||
|
Arm title
|
QIV-SD | |||||||||
Arm description |
Subjects who received Quadrivalent Influenza Vaccine - Standard-Dose. | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
InfluvacTetra
|
|||||||||
Investigational medicinal product code |
||||||||||
Other name |
||||||||||
Pharmaceutical forms |
Suspension for injection in pre-filled syringe
|
|||||||||
Routes of administration |
Injection , Intramuscular use
|
|||||||||
Dosage and administration details |
Each 0.5mL dose contains 15 μg hemagglutinin (HA) of each influenza strain. Strains were determined based on World Health Organization (WHO) and European Union (EU) recommendations for the 2021-2022 Northern Hemisphere (NH) influenza season.
Injected into the upper arm (deltoid area).
|
|||||||||
| Notes [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period. Justification: Visit 1 correspond to the inclusion visit and informed consent form signature (= Day -7). Visit 2 will take place 7 days after Visit 1, and correspond to the randomization and vaccine administration (= Day 0). |
||||||||||
|
||||||||||
|
Period 3
|
||||||||||
Period 3 title |
Visit 3: 1 days after vaccination visit
|
|||||||||
Is this the baseline period? |
No | |||||||||
Allocation method |
Randomised - controlled
|
|||||||||
Blinding used |
Not blinded | |||||||||
|
Arms
|
||||||||||
Are arms mutually exclusive |
Yes
|
|||||||||
|
Arm title
|
QIV-HD | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Efluelda
|
|||||||||
Investigational medicinal product code |
||||||||||
Other name |
||||||||||
Pharmaceutical forms |
Suspension for injection in pre-filled syringe
|
|||||||||
Routes of administration |
Injection , Intramuscular use
|
|||||||||
Dosage and administration details |
Dose: Each 0.7mL dose contains 60 μg hemagglutinin (HA) of each influenza strain. Strains were determined based on World Health Organization (WHO) and European Union (EU) recommendations for the 2021-2022 Northern Hemisphere (NH) influenza season.
Injected into the upper arm (deltoid area).
|
|||||||||
|
Arm title
|
QIV-SD | |||||||||
Arm description |
- | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
InfluvacTetra
|
|||||||||
Investigational medicinal product code |
||||||||||
Other name |
||||||||||
Pharmaceutical forms |
Suspension for injection in pre-filled syringe
|
|||||||||
Routes of administration |
Injection , Intramuscular use
|
|||||||||
Dosage and administration details |
Each 0.5mL dose contains 15 μg hemagglutinin (HA) of each influenza strain. Strains were determined based on World Health Organization (WHO) and European Union (EU) recommendations for the 2021-2022 Northern Hemisphere (NH) influenza season.
Injected into the upper arm (deltoid area).
|
|||||||||
|
||||||||||
|
Period 4
|
||||||||||
Period 4 title |
Visit 4: 21 days after vaccination visit
|
|||||||||
Is this the baseline period? |
No | |||||||||
Allocation method |
Randomised - controlled
|
|||||||||
Blinding used |
Not blinded | |||||||||
|
Arms
|
||||||||||
Are arms mutually exclusive |
Yes
|
|||||||||
|
Arm title
|
QIV-HD | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Efluelda
|
|||||||||
Investigational medicinal product code |
||||||||||
Other name |
||||||||||
Pharmaceutical forms |
Suspension for injection in pre-filled syringe
|
|||||||||
Routes of administration |
Injection , Intramuscular use
|
|||||||||
Dosage and administration details |
Dose: Each 0.7mL dose contains 60 μg hemagglutinin (HA) of each influenza strain. Strains were determined based on World Health Organization (WHO) and European Union (EU) recommendations for the 2021-2022 Northern Hemisphere (NH) influenza season.
Injected into the upper arm (deltoid area).
|
|||||||||
|
Arm title
|
QIV-SD | |||||||||
Arm description |
- | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
InfluvacTetra
|
|||||||||
Investigational medicinal product code |
||||||||||
Other name |
||||||||||
Pharmaceutical forms |
Suspension for injection in pre-filled syringe
|
|||||||||
Routes of administration |
Injection , Intramuscular use
|
|||||||||
Dosage and administration details |
Each 0.5mL dose contains 15 μg hemagglutinin (HA) of each influenza strain. Strains were determined based on World Health Organization (WHO) and European Union (EU) recommendations for the 2021-2022 Northern Hemisphere (NH) influenza season.
Injected into the upper arm (deltoid area).
|
|||||||||
|
||||||||||
|
Period 5
|
||||||||||
Period 5 title |
Visit 5: 90 days after vaccination visit
|
|||||||||
Is this the baseline period? |
No | |||||||||
Allocation method |
Randomised - controlled
|
|||||||||
Blinding used |
Not blinded | |||||||||
|
Arms
|
||||||||||
Are arms mutually exclusive |
Yes
|
|||||||||
|
Arm title
|
QIV-HD | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Efluelda
|
|||||||||
Investigational medicinal product code |
||||||||||
Other name |
||||||||||
Pharmaceutical forms |
Suspension for injection in pre-filled syringe
|
|||||||||
Routes of administration |
Injection , Intramuscular use
|
|||||||||
Dosage and administration details |
Dose: Each 0.7mL dose contains 60 μg hemagglutinin (HA) of each influenza strain. Strains were determined based on World Health Organization (WHO) and European Union (EU) recommendations for the 2021-2022 Northern Hemisphere (NH) influenza season.
Injected into the upper arm (deltoid area).
|
|||||||||
|
Arm title
|
QIV-SD | |||||||||
Arm description |
- | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
InfluvacTetra
|
|||||||||
Investigational medicinal product code |
||||||||||
Other name |
||||||||||
Pharmaceutical forms |
Suspension for injection in pre-filled syringe
|
|||||||||
Routes of administration |
Injection , Intramuscular use
|
|||||||||
Dosage and administration details |
Each 0.5mL dose contains 15 μg hemagglutinin (HA) of each influenza strain. Strains were determined based on World Health Organization (WHO) and European Union (EU) recommendations for the 2021-2022 Northern Hemisphere (NH) influenza season.
Injected into the upper arm (deltoid area).
|
|||||||||
|
||||||||||
|
Period 6
|
||||||||||
Period 6 title |
Visit6: 210 days after vaccination visit
|
|||||||||
Is this the baseline period? |
No | |||||||||
Allocation method |
Randomised - controlled
|
|||||||||
Blinding used |
Not blinded | |||||||||
|
Arms
|
||||||||||
Are arms mutually exclusive |
Yes
|
|||||||||
|
Arm title
|
QIV-HD | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Efluelda
|
|||||||||
Investigational medicinal product code |
||||||||||
Other name |
||||||||||
Pharmaceutical forms |
Suspension for injection in pre-filled syringe
|
|||||||||
Routes of administration |
Injection , Intramuscular use
|
|||||||||
Dosage and administration details |
Dose: Each 0.7mL dose contains 60 μg hemagglutinin (HA) of each influenza strain. Strains were determined based on World Health Organization (WHO) and European Union (EU) recommendations for the 2021-2022 Northern Hemisphere (NH) influenza season.
Injected into the upper arm (deltoid area).
|
|||||||||
|
Arm title
|
QIV-SD | |||||||||
Arm description |
- | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
InfluvacTetra
|
|||||||||
Investigational medicinal product code |
||||||||||
Other name |
||||||||||
Pharmaceutical forms |
Suspension for injection in pre-filled syringe
|
|||||||||
Routes of administration |
Injection , Intramuscular use
|
|||||||||
Dosage and administration details |
Each 0.5mL dose contains 15 μg hemagglutinin (HA) of each influenza strain. Strains were determined based on World Health Organization (WHO) and European Union (EU) recommendations for the 2021-2022 Northern Hemisphere (NH) influenza season.
Injected into the upper arm (deltoid area).
|
|||||||||
|
||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
QIV-HD
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects who receive the Sanofi Pasteur Quadrivalent Influenza Vaccine High-Dose Quadrivalent vaccine. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
QIV-SD
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects who received Quadrivalent Influenza Vaccine - Standard-Dose. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Subject analysis sets
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set title |
Full Analysis Set (FAS)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The Full analysis set (FAS) was comprised of the 59 trial participants who received one dose of the study vaccines and had a post-vaccination blood sample. Participants were randomized with equal probability into two subsets: QIV-SD (N = 28) and QIV-HD (N = 31) vaccine groups.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set title |
Per Protocol (PP)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set type |
Per protocol | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The Per protocol (PP) population is strictly overlapping with the FAS
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set title |
Safety Set (SS)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set type |
Safety analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The Safety set (SS) population is strictly overlapping with the FAS
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
|
End points reporting groups
|
|||
Reporting group title |
QIV-HD
|
||
Reporting group description |
- | ||
Reporting group title |
QIV-SD
|
||
Reporting group description |
- | ||
Reporting group title |
QIV-HD
|
||
Reporting group description |
Subjects who receive the Sanofi Pasteur Quadrivalent Influenza Vaccine High-Dose Quadrivalent vaccine. | ||
Reporting group title |
QIV-SD
|
||
Reporting group description |
Subjects who received Quadrivalent Influenza Vaccine - Standard-Dose. | ||
Reporting group title |
QIV-HD
|
||
Reporting group description |
- | ||
Reporting group title |
QIV-SD
|
||
Reporting group description |
- | ||
Reporting group title |
QIV-HD
|
||
Reporting group description |
- | ||
Reporting group title |
QIV-SD
|
||
Reporting group description |
- | ||
Reporting group title |
QIV-HD
|
||
Reporting group description |
- | ||
Reporting group title |
QIV-SD
|
||
Reporting group description |
- | ||
Reporting group title |
QIV-HD
|
||
Reporting group description |
- | ||
Reporting group title |
QIV-SD
|
||
Reporting group description |
- | ||
Subject analysis set title |
Full Analysis Set (FAS)
|
||
Subject analysis set type |
Full analysis | ||
Subject analysis set description |
The Full analysis set (FAS) was comprised of the 59 trial participants who received one dose of the study vaccines and had a post-vaccination blood sample. Participants were randomized with equal probability into two subsets: QIV-SD (N = 28) and QIV-HD (N = 31) vaccine groups.
|
||
Subject analysis set title |
Per Protocol (PP)
|
||
Subject analysis set type |
Per protocol | ||
Subject analysis set description |
The Per protocol (PP) population is strictly overlapping with the FAS
|
||
Subject analysis set title |
Safety Set (SS)
|
||
Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
The Safety set (SS) population is strictly overlapping with the FAS
|
||
|
|||||||||||||||||||||||||||||||||||||||||||||
End point title |
Immunogenicity [1] | ||||||||||||||||||||||||||||||||||||||||||||
End point description |
Parameters were presented by vaccine group, and against flu strain, with their 95% Confidence Interval (95%CI) for D21, D90, and D210:
1. Geometric Mean (GM) of titers on D0 and (D21, D90, D210) with and without log transformation
2. Distribution of titers against flu
3. Rate of subjects with titer ≥ 1:10 on D0 and (D21, D90, D210)
4. Rate of subjects with titer ≥ 1:40 on D0 and (D21, D90, D210) - Seroprotection
5. Seroconversion or significant increase rate from D0 to (D21, D90, D210)
6. GM of titer ratio (D21, D90, D210)/D0 (immunological response):
a. Individual evolution of ratios
b. Distribution of evolution of ratios
c. Mean evolution of ratios
7. Evolution of (log) antibody titers over time
|
||||||||||||||||||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
D0, D21, D90, and D210
|
||||||||||||||||||||||||||||||||||||||||||||
| 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: Multiple influenza strains |
|||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||
End point title |
Transcriptomic | ||||||||||||||||
End point description |
See protocol
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
D0 and D1
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||
End point title |
Safety | ||||||||||||
End point description |
Occurence of ILI and other adverse events
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
D0 to D210
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Adverse events information [1]
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
Immediate Post-vaccination Observation Period : participants will be kept under observation for 15 minutes after each vaccination.
Adverse events of special interest and SAEs will be collected throughout the study from Visit 1 to Visit 6.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse event reporting additional description |
Information on SAEs will be collected and assessed throughout the study, from Visit 1 to Visit 6. However, before the first study product administration, only SAEs related to study procedures are to be collected in the CRF.
All SAEs will be recorded and reported to the Sponsor and under no circumstance should this exceed 24 hours.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
25
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
QIV-HD
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
QIV-SD
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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: 5 serious adverse events. 0 non-serious adverse event. |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
24 Jan 2022 |
- Modification of a non-inclusion criterion (reduction of the vaccination exclusion period in the study to 24 hours after administration of the influenza vaccine instead of 4 weeks, i.e. COVID vaccination possible after the last blood sample in the study, intended for transcriptomic and cytometric analyses).
- Complete pharmacy circuit updated (ordering, labeling, stock management, and InfluvacTetra® vaccine chosen as comparator).
- Updating of the insurance certificate to include 70 patients in order to reach the 60 evaluable patients stipulated in the protocol. |
||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
