Clinical Trials Register

Summary
EudraCT Number:	2015-005482-23
Sponsor's Protocol Code Number:	INFQ3002
National Competent Authority:	Hungary - National Institute of Pharmacy
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2016-05-04
Trial results	View 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

Hungary - National Institute of Pharmacy

A.2

EudraCT number

2015-005482-23

A.3

Full title of the trial

Randomized, Double-Blind and Active-Controlled Study in Children and Adolescents Aged 3–17 Years to Assess the Safety and Immunogenicity of Abbott’s Candidate Quadrivalent Influenza Vaccine and its Non-Inferiority versus Trivalent Influenza Vaccine.

Randomizált, kettős vak és aktív kontrollos vizsgálat 3-17 éves korú gyermekek és serdülők részvételével, az Abbott által előállított kvadrivalens oltóanyagjelölt biztonságosságának és immunogenitásának, valamint a trivalens influenza oltóanyaghoz viszonyított non-inferioritásának értékelésére.

A.3.1

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

A blinded study to compare the safety and immune response in children and adolescents aged 3-17 years between Abbott's Candidate Quadrivalant Influenza and Trivalent Influenza Vaccine.

A.4.1

Sponsor's protocol code number

INFQ3002

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/182/2015

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Abbott Biologicals B.V.
B.1.3.4	Country	Netherlands
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Abbott Biologicals B.V.
B.4.2	Country	Netherlands
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Abbott Biologicals B.V.
B.5.2	Functional name of contact point	Global Clinical Director
B.5.3	Address:
B.5.3.1	Street Address	C.J. van Houtenlaan 36
B.5.3.2	Town/ city	Weesp
B.5.3.3	Post code	1381 CP
B.5.3.4	Country	Netherlands
B.5.4	Telephone number	+31 294 477184
B.5.5	Fax number	+31294 477160
B.5.6	E-mail	serge.vandewitte@abbott.com

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	No
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
D.3.2	Product code	QIV
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 (surface antigen, inactivated)
D.3.9.2	Current sponsor code	QIV
D.3.9.3	Other descriptive name	quadrivalent influenza vaccine
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.3.11 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.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
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	Influvac®
D.2.1.1.2	Name of the Marketing Authorisation holder	Mylan Healthcare GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	Influvac (Tiv containing B Yamagata strain)
D.3.2	Product code	TIV (Yam)
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 (surface antigen, inactivated)
D.3.9.2	Current sponsor code	TIV (Yam)
D.3.9.3	Other descriptive name	trivalent influenza vaccine (Yam)
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.3.11 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.IMP: 3
D.1.2 and D.1.3	IMP Role	Comparator
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	No
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	Influvac (TIV containing B-Victoria strain)
D.3.2	Product code	TIV (Vic)
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 (surface antigen, inactivated)
D.3.9.2	Current sponsor code	TIV (Vic)
D.3.9.3	Other descriptive name	trivalent influenza vaccine (Vic)
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.3.11 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

E.1.1.1

Medical condition in easily understood language

Prevention of Influenza (flu) Infection

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	19.0
E.1.2	Level	HLT
E.1.2	Classification code	10022005
E.1.2	Term	Influenza viral infections
E.1.2	System Organ Class	100000004862

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 demonstrate in a population of children and adolescents 3 to 17 years of age the non-inferiority of quadrivalent influenza vaccine (QIV) with respect to post-vaccination geometric mean Hemagglutination Inhibition (HI) antibody titers against the shared strains compared with the trivalent influenza vaccines (TIV) with either the B-strain of the Victoria (TIV(Vic)) or the B-strain of the Yamagata lineage (TIV(Yam)).

E.2.2

Secondary objectives of the trial

1.To demonstrate the superiority of QIV to TIV(Vic) and TIV(Yam)with respect to post-vaccination geometric mean HI antibody titers against the alternate-lineage B strain in a population of children and adolescents 3 to 17 years of age.
2.To describe the immunogenicity of each of the strains in QIV with respect to HI, Virus Neutralization (VN) and Neuraminidase Inhibition (NI) antibody titers in the study population overall and by subject age, preexisting antibody status and baseline health status.
3.To describe Cell-Mediated Immunity (CMI) values for a subset of subjects.
Safety Objective:
To compare the reactogenicity and safety of QIV with that of TIV in a population of children and adolescents 3 to 17 years of age.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

•Male and female children and adolescents 3 to 17 years of age at the time of enrolment in stable health determined from medical history, physical examination and clinical judgment of the Investigator. Subjects may have underlying illnesses as long as their symptoms/signs are controlled.
•The subject’s parent(s) or LAR(s) sign and date a written, informed consent form (ICF). An assent will also be obtained according to age appropriate country-specific regulations.
•Subject and parent(s) or LAR(s) are able and willing to attend all scheduled visits and to comply with all trial procedures.

E.4

Principal exclusion criteria

1.Child in care (as defined in the protocol)
2.History of allergy to egg, chicken proteins, or history of any reaction or hypersensitivity to a previous dose of influenza vaccine components.
3.History of serious adverse reaction to any influenza vaccine.
4.History of Guillain-Barré syndrome.
5.History of seizures (subject who had a single uncomplicated febrile convulsion in the past could be included) or progressive neurological disease.
6.Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
7.Prior receipt of any seasonal or pandemic influenza vaccine (registered or investigational) or laboratory-confirmed influenza infection in the 6 months preceding the first study vaccination.
8.Receipt of any vaccine (including routine childhood vaccines) within the preceding 30 days or planned vaccination during the study within 30 days after any study vaccine administration.
9.Having fever and/or acute disease or infection on the day of first study vaccination (enrolment can be deferred for up to 2 weeks provided subject remains otherwise eligible).
10.Any known immunocompromising condition or immunosuppressive therapy within 6 months preceding enrolment.
11.Chronic systemic administration (defined as more than 14 days) of immunosuppressant or immune-modifying medication (such as corticosteroids and monoclonal antibodies) during 3 months prior to the first study vaccination or planned use thereof during the study. Topical use of corticosteroids (e.g., cream, ocular drops, inhalation and intranasal sprays), within the dosage noted on the product label, is allowed.
12. Any condition that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine including (but not limited to) bleeding disorder, acute or progressive clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and/or physical examination.

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint concerns the geometric mean HI antibody titers against the 4 vaccine strains

E.5.1.1

Timepoint(s) of evaluation of this end point

28 days after study vaccination (Day 29, primed subjects) or 28 days after the second study vaccination (Day 57, unprimed subjects).

E.5.2

Secondary end point(s)

The secondary endpoints concern:
1)Change from baseline geometric mean HI antibody titers against the 4 vaccine strains.
2)Post-vaccination geometric mean VN and NI antibody titers and change from baseline against the 4 vaccine strains for a randomized subset of subjects.
3)Seroconversion rates and geometric mean fold increases for HI, VN and NI for the 4 vaccine strains for a randomized subset of subjects.
4)Post-vaccination CMI values for a subset of subjects and change from baseline.
Safety points:
1)All unsolicited (spontaneously reported) AEs
2)SAEs, AESIs and NCIs
3) Solicited injection site reactions and systemic reactions

E.5.2.1

Timepoint(s) of evaluation of this end point

1)2)3)4: Day 29 for primed subjects
Day 57 for unprimed subjects

For Safety points:
1) From ICF signature to Day 29 (primed subjects) or Day 57 (unprimed subjects)
2) from ICF signature to final follow-up telephone call approximately 6 months later (Day 183)
3) within 7 days following each study vaccination.

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

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 and reactogenicity

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)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

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)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

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

LVLS (last visit is the safety follow up phone contact at Day 183)

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

E.8.9.2

In all countries concerned by the trial months

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:

1200

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)

Yes

F.1.1.5.1

Number of subjects for this age range:

900

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

300

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

Yes

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

minors

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

230

F.4.2

For a multinational trial

F.4.2.1

In the EEA

1200

F.4.2.2

In the whole clinical trial

1200

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)

N/A

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

2016-06-24

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-06-22

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2017-04-14

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