Clinical Trials Register

Summary
EudraCT Number:	2021-003760-27
Sponsor's Protocol Code Number:	INCENTIVE-QIV-3-EU
National Competent Authority:	Belgium - FPS Health-DGM
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-07-30
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

2021-003760-27

A.3

Full title of the trial

INCENTIVE-QIV-3-EU: Immunogenicity, molecular profiling of a marketed quadrivalent influenza vaccine (Vaxigrip Tetra®) administered by the intramuscular route in participants aged 6 to 8 months

A.3.1

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

Study of the immune response to influenza vaccine in children aged 6 to 8 months.

Etude de la réponse immunitaire au vaccin de la grippe chez des enfants de 6 à 8 mois.

A.3.2

Name or abbreviated title of the trial where available

INCENTIVE-QIV-3-EU

A.4.1

Sponsor's protocol code number

INCENTIVE-QIV-3-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	Université Libre de Bruxelles
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	European Union
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	CHU Saint Pierre
B.5.2	Functional name of contact point	Dr Tessa Goetghebuer
B.5.3	Address:
B.5.3.1	Street Address	Rue Haute, 322
B.5.3.2	Town/ city	Bruxelles
B.5.3.3	Post code	1000
B.5.3.4	Country	Belgium
B.5.4	Telephone number	+3225354369
B.5.5	Fax number	+3225354171
B.5.6	E-mail	tessa.goetghebuer@stpierre-bru.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
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.3.1	Product name	Quadrivalent Influenza Vaccine(split-virion, inactivated)
D.3.4	Pharmaceutical form	Suspension 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
D.3.9.4	EV Substance Code	SUB12066MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	15
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/DARWIN/9/2021(H3N2)like strain (A/DARWIN/9/2021, IVR-228)
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	equal
D.3.10.3	Concentration number	15
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/AUSTRIA/1359417/2021-like strain (B/MICHIGAN/01/2021, 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	equal
D.3.10.3	Concentration number	15
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, wild type
D.3.9.4	EV Substance Code	SUB12066MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg/l microgram(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	15
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

Prophylaxis of Influenza (Northern Hemispher 2021-2022 and 2022-2023 season) in Children aged 6-8 months

E.1.1.1

Medical condition in easily understood language

Prophylaxis of Influenza (Northern Hemispher 2021-2022 season and 2022-2023 season) in Children aged 6-8 months

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

Immunogenicity - To measure the level of immune response [HAI-haemagglutinin Antibody Inhibition titres] of 2 intramuscular doses of the quadrivalent inactivated influenza vaccine (Vaxigrip Tetra®) in healthy participants aged 6 to 8 months

E.2.2

Secondary objectives of the trial

• To measure the levels, avidity, biophysical characteristics and functionality of influenza-specific antibodies induced by the vaccine
• To measure the functional programming of peripheral blood immune cells (transcriptome and phenotype), the plasma proteome and metabolome before and after vaccination

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Male or female infants born at ≥ 36 weeks of gestation and aged 6 to 8 months
Provide written informed consent from parents.
The parents are willing to comply with study protocol requirements, including availability for all scheduled visits of the study.
Subjects are healthy or with well-controlled pre-existing medical conditions by the opinion of the investigator

E.4

Principal exclusion criteria

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. Current or previous, laboratory confirmed case of influenza during the past 6 months, based on anamnesis or medical file (if available) at screening visit
4. Household contact with and/or intimate exposure to an individual with any laboratory confirmed influenza infection during the past 6 months prior to vaccination.
5. History of severe allergic reactions after previous vaccinations or hypersensitivity to any study vaccine component
6. Previous history of Guillain Barre Syndrome.
7. Any confirmed or suspected condition with impaired/altered function of immune system (e.g. immunodeficient or autoimmune conditions).
8. Having tested positive for Human Immuno-deficiency Virus (HIV), Hepatitis B or Hepatitis C
9. Having any bleeding disorder which is considered as a contraindication to intramuscular injection or blood draw according to the opinion of the investigator
10. 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.
11. 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.;
12. Administration of any vaccine within 28 days prior to enrolment in the study or planned administration of any vaccine during study participation.
13. 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.
14. Having received systemic antibiotic treatment within 3 days prior to enrolment.
15. 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
16. 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 D58
• Proportion of participants with HAI titres ≥ 40 (1/dilution) at D58
• HAI antibody titres fold increase between D0 and D58
• Proportion of participants with Seroconversion (titre < 10 [1/dilution] at D0 and post-vaccination titre ≥ 40 [1/dilution] at D58, or titre ≥ 10 [1/dilution] at D0 and a ≥ 4-fold increase in titre [1/dilution] at D58
• Proportion of high and low responders (HAI titres <40 (1/dilution) at D58)

E.5.1.1

Timepoint(s) of evaluation of this end point

D3 and D58

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

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

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

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in 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

Yes

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

LSLV

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

Yes

F.1.1

Number of subjects for this age range:

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)

Yes

F.1.1.4.1

Number of subjects for this age range:

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

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

Yes

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Consent will be given by parents

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

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)

Not applicable

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2021-08-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-09-21

P. End of Trial
P.	End of Trial Status	Ongoing

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