Clinical Trials Register

Summary
EudraCT Number:	2014-001042-24
Sponsor's Protocol Code Number:	INFQ3001
National Competent Authority:	Lithuania - SMCA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2015-01-28
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

Lithuania - SMCA

A.2

EudraCT number

2014-001042-24

A.3

Full title of the trial

Randomized, Double-Blind, Active-Controlled Study in Adults to Assess the Safety and Immunogenicity of Abbott’s Candidate Quadrivalent Influenza Vaccine and its Non-Inferiority to Trivalent Influenza Vaccine.

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 adults of Abbott’s Candidate Quadrivalent Influenza and Abbott's known Trivalent Influenza Vaccine.

A.4.1

Sponsor's protocol code number

INFQ3001

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	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	3129447 7184
B.5.5	Fax number	3129447 7160
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 S
D.2.1.1.2	Name of the Marketing Authorisation holder	Abbott B.V.
D.2.1.2	Country which granted the Marketing Authorisation	Lithuania
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	trivalent 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 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	18.0
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.1.2 Medical condition or disease under investigation

E.1.2	Version	18.0
E.1.2	Level	PT
E.1.2	Classification code	10062297
E.1.2	Term	Immunology test
E.1.2	System Organ Class	10022891 - Investigations

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.0
E.1.2	Level	PT
E.1.2	Classification code	10065109
E.1.2	Term	Reactogenicity event
E.1.2	System Organ Class	10018065 - General disorders and administration site conditions

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 subjects ≥ 18 years of age the non-inferiority of QIV with respect to post-vaccination geometric mean hemagglutinin 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

To demonstrate in subjects ≥ 18 years of age the superiority of QIV to TIV(Vic) and TIV(Yam) with respect to post-vaccination geometric mean hemagglutinin inhibition (HI) antibody titers against the alternate-lineage B strain.

To describe the immunogenicity with respect to HI and virus neutralization (VN) antibody titers using the derived serology parameters seroconversion and geometric mean fold increase for each of the strains in QIV and TIV, in adults (≥ 18 to ≤ 60 years of age) and elderly (≥ 61 years of age).

To describe the immunogenicity with respect to HI and VN antibody titers in study population subsets according to age and pre-existing antibody status for each of the strains in QIV and TIV.
To describe cell-mediated immunity values for a subset of subjects.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Willing and able to give informed consent and able to adhere to all protocol required study procedures.
2. Men and women aged ≥ 18 years of age at the day of study vaccination.
3. Being in good health as judged by medical history, physical examination and clinical judgment of the Investigator (subjects may have underlying chronic illnesses such as hypertension, diabetes, ischemic heart disease or hypothyroidism, as long as their symptoms/signs are controlled. If on regular prescribed medication for a condition, the medication dose must have been stable for at least three months preceding study vaccination).

E.4

Principal exclusion criteria

1. History of allergy to egg, chicken proteins, or other vaccine components.
2. History of serious adverse reaction to any influenza vaccine.
3. History of Guillain-Barré syndrome.
4. Confirmed influenza infection or vaccination against influenza in the 6 months preceding enrollment.
5. Receipt of any vaccine within the preceding 4 weeks prior to study vaccination or planned vaccination during the study between Visit 1 (Day 1) and Visit 2 (Day 22).
6. Having fever and/or presenting with an acute disease or infection on the day of study vaccination. Fever is defined as an oral temperature of ≥ 38.0 ºC.
7. Any known immunocompromising condition or immunosuppressive therapy within 6 months preceding study vaccination.
8. Using or having used medication that influences the immune system (such as corticosteroids and monoclonal antibodies) during the four weeks prior to the study or planned use thereof during the study. Topical use of corticosteroids (i.e., cream, ocular drops, inhalation and intranasal sprays), within the dosage noted on the product label, is allowed.
9. Receipt of blood or blood products within the 3 months preceding enrollment.
10. Participation in a placebo-controlled influenza vaccine clinical trial any time prior to entering this study if the treatment arm is not known.
11. 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 study vaccine including (but not limited to) bleeding disorder, known immunodeficiency, seizure disorder, acute, severe or progressive hepatic, renal, neurological or neuromuscular disease.
12. Being a solid organ or bone marrow/stem cell transplant recipient.
13. Use of cytotoxic drugs, anticancer chemotherapy or radiation therapy within 36 months before the day of study vaccination.

E.5 End points

E.5.1

Primary end point(s)

Non-inferiority will be inspected by calculating for each of the two A-strains and each of the two B-strains a two-sided 95% confidence interval for geometric mean ratios (GMRs) for the contrast TIV versus QIV, using an analysis of variance model for the log-transformed titers

E.5.1.1

Timepoint(s) of evaluation of this end point

Visit 2 (Day 22 -2/+4 days)

E.5.2

Secondary end point(s)

Overall Safety

E.5.2.1

Timepoint(s) of evaluation of this end point

At each visit or phone contact

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

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

Last Subject Last Visit (Phone contact 2, 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 years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial 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:

1140

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

840

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

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

416

F.4.2

For a multinational trial

F.4.2.1

In the EEA

1980

F.4.2.2

In the whole clinical trial

1980

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)

Subjects are expected to be in good health and will continue standard of care.

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

2015-05-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-03-18

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2016-01-06

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