Clinical Trials Register

Summary
EudraCT Number:	2021-003307-18
Sponsor's Protocol Code Number:	INCENTIVE-QIV-1-EU
National Competent Authority:	Belgium - FPS Health-DGM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-06-21
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Belgium - FPS Health-DGM

A.2

EudraCT number

2021-003307-18

A.3

Full title of the trial

Immunogenicity, molecular profiling and safety of a marketed quadrivalent influenza vaccine (Vaxigrip Tetra®) administered by the intramuscular route in participants 60 years of age and older

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Immunity to influenza virus disease and safety of Vaxigrip Tetra® (commercial vaccine with protection against 4 types of influenza virus) in participants 60 years and older

A.4.1

Sponsor's protocol code number

INCENTIVE-QIV-1-EU

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	University of Antwerp
B.1.3.4	Country	Belgium
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	EU_Horizon 2020
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	University of Antwerp
B.5.2	Functional name of contact point	Ilse De Coster
B.5.3	Address:
B.5.3.1	Street Address	Universiteitsplein 1, Campus Drie Eiken, Building S
B.5.3.2	Town/ city	Wilrijk
B.5.3.3	Post code	2610
B.5.3.4	Country	Belgium
B.5.4	Telephone number	+3232652676
B.5.5	Fax number	+3232652404
B.5.6	E-mail	ilse.decoster@uantwerpen.be

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Vaxigrip Tetra
D.2.1.1.2	Name of the Marketing Authorisation holder	Sanofi Pasteur Europe
D.2.1.2	Country which granted the Marketing Authorisation	Belgium
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Solution for injection in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
D.3.9.3	Other descriptive name	A/Victoria/2570/2019 (H1N1)pdm09 – achtige stam (A/Victoria/2570/2019, IVR- 215)
D.3.9.4	EV Substance Code	SUB12066MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	30
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
D.3.9.3	Other descriptive name	A/Cambodia/e0826360/2020 (H3N2) – achtige stam (A/Tasmania/503/2020, IVR-221)
D.3.9.4	EV Substance Code	SUB12066MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	30
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
D.3.9.3	Other descriptive name	B/Washington/02/2019 - achtige stam (B/Washington/02/2019, wild type)
D.3.9.4	EV Substance Code	SUB12066MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	30
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
D.3.9.3	Other descriptive name	B/Phuket/3073/2013 - achtige stam (B/Phuket/3073/2013, wild type)
D.3.9.4	EV Substance Code	SUB12066MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	30
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Influenza

E.1.1.1

Medical condition in easily understood language

flu

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To measure the level of immune response [HAI-haemagglutinin Antibody Inhibition titres] of a single intramuscular dose of the quadrivalent inactivated influenza vaccine (Vaxigrip Tetra®) in healthy participants aged 60 years and above

E.2.2

Secondary objectives of the trial

Not applicable

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Eligible participants must meet all of the below criteria at the time of enrolment:
1. Male or female of non-child bearing potential 60 years and above at the time of study
2. Provide written informed consent.
3. The participant is willing to comply with study protocol requirements, including availability for all scheduled visits of the study.
4. Subjects are healthy or with well-controlled pre-existing medical conditions by the opinion of the investigator

E.4

Principal exclusion criteria

Participants meeting any of the below criteria at the time of enrolment will be ineligible to participate in the trial:
1. Acute illness, at the time of study vaccine administration (once acute illness is resolved, if appropriate, as per investigator assessment, participant will be re-revaluated for eligibility).
2. Recorded fever (for eligibility purpose defined as a body temperature greater than 37.5°C) within 3 days prior to study vaccine administration (once fever/acute illness is resolved, if appropriate, as per investigator assessment, participant will be re-evaluated for eligibility.
3. Not willing to refrain from physical exercise during 48 hours prior to vaccination
4. History of any influenza vaccine administration during the past 6 months and during study participation.
5. Current or previous, laboratory confirmed case of influenza during the past 6 months, based on anamnesis or medical file (if available) at screening visit
6. Household contact with and/or intimate exposure to an individual with any laboratory confirmed influenza infection during the past 6 months prior to vaccination.
7. History of severe allergic reactions after previous vaccinations or hypersensitivity to any study vaccine component
8. Previous history of Guillain Barre Syndrome.
9. Any confirmed or suspected condition with impaired/altered function of immune system (e.g. immunodeficient or autoimmune conditions).
10. Having tested positive for Human Immuno-deficiency Virus (HIV), Hepatitis B or Hepatitis C on the blood tests of the screening visit
11. Having any bleeding disorder which is considered as a contraindication to intramuscular injection or blood draw according to the opinion of the investigator
12. Chronic administration (defined as more than 14 days) of immunosuppressant or other immune-modifying drugs within three months prior to the study vaccination or planned use throughout the study period. (For corticosteroids, this means prednisone, or equivalent, ≥ 0.5 mg/kg per day. Inhaled, intranasal and topical steroids are allowed.
13. Neoplastic disease or any hematologic malignancy (except localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy and subjects who have a history of neoplastic disease and have been disease-free for ≥5 years).
14. Administration of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 3 months or planned use throughout the study period.;
15. Administration of any vaccine within 28 days prior to enrolment in the study (except for influenza vaccine which should be >6 months prior to enrollment) or planned administration of any vaccine during study participation.
16. Use of any investigational or non-registered drug or vaccine within 30 days prior to the administration of study vaccines or planned during the study.
17. Having received systemic antibiotic treatment within 3 days prior to enrolment.
18. Acute or chronic, clinically significant pulmonary, cardiovascular, metabolic, neurological, hepatic, or renal functional abnormality, as determined by medical history or physical examination if uncontrolled or without appropriate treatment
19. Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the volunteer participating in the study or make it unlikely that the participant could complete the protocol.

E.5 End points

E.5.1

Primary end point(s)

• HAI antibody titres on D0 and D28
• Proportion of participants with HAI titres ≥ 40 (1/dilution) at D28
• HAI antibody titres fold increase between D0 and D28
• Proportion of participants with Seroconversion (titre < 10 [1/dilution] at D0 and post-vaccination titre ≥ 40 [1/dilution] at D28, or titre ≥ 10 [1/dilution] at D0 and a ≥ 4-fold increase in titre [1/dilution] at D28
• Proportion of high and low responders (HAI titres <40 (1/dilution) at D28)

E.5.1.1

Timepoint(s) of evaluation of this end point

E.5.2

Secondary end point(s)

Not applicable

E.5.2.1

Timepoint(s) of evaluation of this end point

Not applicable

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

- Immunogenicity
- Molecular profiling

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

end of trial is last visit of last subject

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

Yes

F.3.2

Patients

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.2

In the whole clinical trial

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2021-07-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-07-05

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2022-02-02

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