Clinical Trials Register

Summary
EudraCT Number:	2012-000218-12
Sponsor's Protocol Code Number:	V118_05
National Competent Authority:	Finland - Fimea
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2013-08-06
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

Finland - Fimea

A.2

EudraCT number

2012-000218-12

A.3

Full title of the trial

A Phase III, Stratified, Randomized, Observer Blind, Controlled, Multicenter Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children ≥6 to < 72 Months of Age

A.3.1

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

Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of Investigational Flu Vaccine Compared to Approved Flu Vaccine (Fluzone) in Children

A.4.1

Sponsor's protocol code number

V118_05

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	Seqirus UK Limited
B.1.3.4	Country	United Kingdom
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	Seqirus UK Limited
B.4.2	Country	United Kingdom
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Seqirus, Inc
B.5.2	Functional name of contact point	Mary Ellen Ruzycky, MS
B.5.3	Address:
B.5.3.1	Street Address	75 Sidney Street
B.5.3.2	Town/ city	Cambridge
B.5.3.3	Post code	MA 02138
B.5.3.4	Country	United States
B.5.4	Telephone number	+1617.871.8226
B.5.6	E-mail	mary_ellen.ruzycky@seqirus.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	Adjuvanted Quadrivalent Influenza Vaccine (aQIV) -surface antigen, inactivated, adjuvanted with MF59
D.3.2	Product code	aQIV
D.3.4	Pharmaceutical form	Suspension for injection
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	A/ (H1N1) - like virus antigen
D.3.9.3	Other descriptive name	A/ (H1N1)-LIKE VIRUS ANTIGEN
D.3.9.4	EV Substance Code	SUB117552
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	30
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	A/ (H3N2) - like virus antigen
D.3.9.3	Other descriptive name	A/ (H3N2)-LIKE VIRUS ANTIGEN
D.3.9.4	EV Substance Code	SUB117553
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	30
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	B/ (Yamagata) - like virus antigen
D.3.9.3	Other descriptive name	B/ -LIKE VIRUS ANTIGEN
D.3.9.4	EV Substance Code	SUB117554
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	30
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	B/ (Victoria) - like virus antigen
D.3.9.3	Other descriptive name	B/ -LIKE VIRUS ANTIGEN
D.3.9.4	EV Substance Code	SUB117554
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	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.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	Fluzone Quadrivalent
D.2.1.1.2	Name of the Marketing Authorisation holder	Sanofi Pasteur Inc.
D.2.1.2	Country which granted the Marketing Authorisation	United States
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	Fluzone Quadrivalent (Influenza Virus Vaccine)
D.3.2	Product code	Fluzone QIV
D.3.4	Pharmaceutical form	Suspension for injection
D.3.4.1	Specific paediatric formulation	Yes
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	A/ (H1N1) - like virus antigen
D.3.9.3	Other descriptive name	A/ (H1N1)-LIKE VIRUS ANTIGEN
D.3.9.4	EV Substance Code	SUB117552
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	30
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	A/ (H3N2) - like virus antigen
D.3.9.3	Other descriptive name	A/ (H3N2)-LIKE VIRUS ANTIGEN
D.3.9.4	EV Substance Code	SUB117553
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	30
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	B/ (Yamagata) - like virus antigen
D.3.9.3	Other descriptive name	B/ -LIKE VIRUS ANTIGEN
D.3.9.4	EV Substance Code	SUB117554
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	30
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	B/ (Victoria) - like virus antigen
D.3.9.3	Other descriptive name	B/ -LIKE VIRUS ANTIGEN
D.3.9.4	EV Substance Code	SUB117554
D.3.10	Strength
D.3.10.1	Concentration unit	µl/ml microlitre(s)/millilitre
D.3.10.2	Concentration type	equal
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

Prophylaxis for influenza virus

E.1.1.1

Medical condition in easily understood language

Flu virus

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	PT
E.1.2	Classification code	10022000
E.1.2	Term	Influenza
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The relative efficacy of aQIV compared to comparator vaccine as determined by RT-PCR-confirmed influenza

E.2.2

Secondary objectives of the trial

* The relative efficacy of aQIV compared to comparator as determined by the proportion of subjects with culture-confirmed influenza
* The relative efficacy of aQIV compared to comparator as determined by RT-PCR-confirmed influenza in age subgroups, in children at risk of influenza, and in children depending on previous vaccination status
* The early relative efficacy of aQIV compared to comparator as determined by RT-PCR-confirmed influenza
To compare antibody * responses between aQIV and comparator (including assessment of non-inferiority and superiority)
* To evaluate healthcare utilization and health economic outcomes
* To evaluate safety and tolerability of each study vaccine

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

* Children, males and females, healthy or at high risk of complications from influenza, between ≥6 months to <72 months of age
* Documented consent provided by the subject’s parent(s)/legal guardian(s)
* Subjects and/or subject’s parent(s)/legal guardian(s) able to comply with all study procedures.

E.4

Principal exclusion criteria

* Subjects with a history of allergy to vaccine components
* Additional eligibility criteria may be discussed by contacting the site

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is on RT-PCR-confirmed influenza cases occurring at ≥21 days and ≤ 180 days after the last vaccination or until the end of the influenza season, whichever is longer.

E.5.1.1

Timepoint(s) of evaluation of this end point

Weekly from Day 1 up to 180 days after the last vaccination or until the end of influenza season, whichever is longer.

E.5.2

Secondary end point(s)

*Secondary efficacy endpoint:
Hazard ratios calculated
1.Occurrence of culture-confirmed influenza cases in all subjects occurring at ≥21 days and ≤ 180 days after the last vaccination or until the end of the influenza season, whichever is longer,
2. Early occurrence of RT-PCR-confirmed influenza cases in all subjects on first-occurrence of RT-PCR-confirmed influenza cases
*Secondary Immunogenicity Endpoints
The endpoints for immunogenicity measured in aQIV and comparator as determined by HI are as follows:
1.Geometric mean HI titer (GMT).
2.Geometric mean ratio (GMR)
3.Percentage of vaccine naïve and non-naïve subjects achieving seroconversion;
4.Percentage of subjects with HI titer ≥ 1:40
5.Percentage of subjects with higher HI titer thresholds
* Other Endpoints (Health Economic Outcome):
1. Number of medical visit for respiratory illness in subjects associated with RT-PCR-confirmed influenza
2.Number of employment days missed by parent(s)/guardian(s) of subjects with RT-PCR-confirmed influenza.
3.Number of days of daycare, school or preschool missed by subjects associated with RT-PCR-confirmed influenza
* Safety Endpoints:
1.Percentages of subjects with solicited AEs.
2.Percentages of subjects with all unsolicited AEs.
3.Percentage of subjects with SAEs, AEs leading to withdrawal from the study or study vaccination, New Onset of Chronic Disease (NOCD), Adverse Events of Special Interest(AESI) and all medications associated.

E.5.2.1

Timepoint(s) of evaluation of this end point

Secondary Immunogenicity Endpoints:
1.vaccine naïve subjects: on Day 1, 29, 50 & 209, vaccine non-naïve subjects: on Day 1, 22 & 181
2.vaccine naïve subjects on Day 29/Day 1, D50/D1 & D209/D1, non-naïve: D22/D1 & D181/D1
3.vaccine naïve subjects: on Day 29 & 50, non-naïve subjects: on Day 22
4.vaccine naïve subjects on Day 29, 50 & 209, non-naïve: Day 22 & 181
5.vaccine naïve subjects on Day 29, 50 & 209, non-naïve: Day 22 & 181
Other Endpoints (Health Economic Outcome):
1.within a window of 14 days after ILI-onset
2.within a window of 14 days after ILI-onset
3.within a window of 14 days after ILI-onset
Safety Endpoints:
1.for 7 days following each vaccination
2.vaccine-naïve subjects: from Day 1 to 50, non-naïve subjects from Day 1 to 22
3. 12 months after last 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
-Health Economic Outcome

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

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Observer blind

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

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Canada

Finland

Italy

Mexico

Philippines

Poland

Russian Federation

Spain

Taiwan

Thailand

United States

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

Completion of testing of the biological samples, to be achieved no
later than 8 months after collection of the last biological sample visit.
Evaluation of the primary and/or secondary immunogenicity/efficacy objectives requires testing of biological samples from study subjects. The last samples for the analysis of such objectives will be taken up to 180 d after the last vaccination (V7: D181 for non-naïve subj. or V9: D209 for naïve) or until end of influenza season, whichever is longer.

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

Yes

F.1.1

Number of subjects for this age range:

13620

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:

6810

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

6810

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

Subjects under age 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

750

F.4.2

For a multinational trial

F.4.2.1

In the EEA

2000

F.4.2.2

In the whole clinical trial

13620

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

2013-09-17

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-09-10

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2016-04-25

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