Clinical Trials Register

Summary
EudraCT Number:	2012-002587-27
Sponsor's Protocol Code Number:	113237
Clinical Trial Type:	Outside EU/EEA
Date on which this record was first entered in the EudraCT database:	2015-06-11
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
H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED

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A. Protocol Information

A.2

EudraCT number

2012-002587-27

A.3

Full title of the trial

A phase II, double-blind, multicenter, randomized study to evaluate the immunogenicity and safety of GSK Biologicals’ quadrivalent influenza candidate vaccine GSK2321138A compared with GSK Biologicals’ trivalent influenza vaccine, Fluarix™, administered intramuscularly in children (18-47 months of age) in both unprimed subjects and in primed subjects who previously participated in the 111751 study

A.3.1

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

Study to evaluate the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ quadrivalent influenza candidate vaccine GSK2321138A (FLU D-QIV), when administered to children 18 to 47 months of age.

A.3.2

Name or abbreviated title of the trial where available

FLU D-QIV-002

A.4.1

Sponsor's protocol code number

113237

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	GlaxoSmithKline Biologicals
B.1.3.4	Country	Belgium
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	GlaxoSmithKline Biologicals
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	GlaxoSmithKline Biologicals
B.5.2	Functional name of contact point	Clinical Disclosure Advisor
B.5.3	Address:
B.5.3.1	Street Address	Rue de l'Institut, 89
B.5.3.2	Town/ city	Rixensart
B.5.3.3	Post code	1330
B.5.3.4	Country	Belgium
B.5.4	Telephone number	442089904466
B.5.6	E-mail	GSKClinicalSupportHD@gsk.com

D. IMP Identification
D.IMP: 1
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	Fluarix™
D.2.1.1.2	Name of the Marketing Authorisation holder	GSK Biologicals s.A.
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.3.4	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	-
D.3.9.2	Current sponsor code	A/Brisbane/59/2007 (H1N1) -like strain
D.3.9.3	Other descriptive name	TRIVALENT INACTIVATED INFLUENZA VACCINE
D.3.9.4	EV Substance Code	SUB129647
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	-
D.3.9.2	Current sponsor code	A/Brisbane/10/2007 (H3N2) -like strain
D.3.9.3	Other descriptive name	TRIVALENT INACTIVATED INFLUENZA VACCINE
D.3.9.4	EV Substance Code	SUB129647
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	-
D.3.9.2	Current sponsor code	B/Brisbane/60/2008 (Victoria-lineage) strain
D.3.9.3	Other descriptive name	TRIVALENT INACTIVATED INFLUENZA VACCINE
D.3.9.4	EV Substance Code	SUB129647
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	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	FLU D-QIV
D.3.2	Product code	GSK2321138A
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	-
D.3.9.2	Current sponsor code	A/Brisbane/59/2007 (H1N1) -like strain
D.3.9.3	Other descriptive name	INFLUENZA VACCINE
D.3.9.4	EV Substance Code	SUB14211MIG
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	-
D.3.9.2	Current sponsor code	A/Brisbane/10/2007 (H3N2) -like strain
D.3.9.3	Other descriptive name	INFLUENZA VACCINE
D.3.9.4	EV Substance Code	SUB14211MIG
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	-
D.3.9.2	Current sponsor code	B/Brisbane/60/2008 (Victoria-lineage) strain
D.3.9.3	Other descriptive name	INFLUENZA VACCINE
D.3.9.4	EV Substance Code	SUB14211MIG
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	-
D.3.9.2	Current sponsor code	B/Brisbane/3/2007 (Yamagata-lineage strain
D.3.9.3	Other descriptive name	INFLUENZA VACCINE
D.3.9.4	EV Substance Code	SUB14211MIG
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

Healthy volunteers (immunisation against influenza in male and female subjects 18 to 47 months of age inclusive).

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 assess the immunological non-inferiority in terms of Geometric Mean Titers (GMTs) of the quadrivalent influ-enza study vaccine (FLU D-QIV) compared to the trivalent influenza vaccine (Fluarix™) in primed and unprimed subjects for the three recommended seasonal strains, 28 days after the last vaccination.

E.2.2

Secondary objectives of the trial

• To assess immunological superiority in terms of GMTs of quadrivalent FLU D-QIV compared to trivalent Fluarix for the B strain not included in the trivalent vaccine.
• To assess the immune response elicited by the study vaccines when primed with B-Yamagata strain and vacci-nated with B-Victoria or B-Yamagata strains:
- To assess the immunological superiority in terms of GMTs for the B-Yamagata strain in primed subjects following one FLU D-QIV dose compared to unprimed subjects
- To assess the immunological superiority in terms of GMTs for the B-Victoria strain in primed subjects following one dose with either Fluarix or FLU D-QIV) compared to unprimed subjects:
• To assess the humoral immune response in each vaccine group
• To assess the safety and reactogenicity of the study vaccines during the entire study period: solicited symptoms during 7 days, unsolicited symptoms during 28 days, adverse events of special interest and serious adverse events during 6 months.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Subject’s parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
• A male or female child between, and including, 18 and 47 months of age at the time of the first vaccination.
• Written informed consent obtained from the par-ent(s)/LAR(s) of the subject.
• Children who had not received 2 doses of influenza vaccine in a previous season.
• In addition, primed subjects from the 111751 study (FluarixUS-007) willing to participate in this study had to satisfy the following criterion at study entry:
• Children who had received 2 doses of Fluarix (0.5 mL) in the 111751 study (FluarixUS-007).

E.4

Principal exclusion criteria

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• History of hypersensitivity to any vaccine.
• History of allergy or reactions likely to be exacerbated by any component of the vaccine (including egg, chicken protein, formaldehyde, gentamicin sulfate or sodium de-oxycholate).
• Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before and ending 28 days after each dose of vaccine(s).
• Acute or chronic clinically significant pulmonary, cardio-vascular, hepatic or renal functional abnormality, as de-termined by medical history and physical examination.
• Acute disease at the time of enrolment. (Acute disease was defined as the presence of a moderate or severe ill-ness with or without fever. All vaccines could be adminis-tered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. oral/axillary temperature <37.5°C (99.5°F) or rectal temperature <38.0°C (100.4°F).
• History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
• Receipt of another seasonal influenza vaccine outside of this study, during current (2009-2010) flu season.
• Any confirmed or suspected immunosuppressive or im-munodeficient condition based on medical history and physical examination (no laboratory testing required).
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccination (for corti-costeroids, this meant prednisone greater than or equal to 10 milligram/day (10 mg/day), or equivalent). Inhaled and topical steroids were allowed.
• Administration of immunoglobulins and/or blood products within the 3 month preceding the first dose of study vac-cine or planned administration during the study period.
• Concurrently participating in another clinical study, at any time during the study period, in which the subject had been or would be exposed to an investigational or a non-investigational product (pharmaceutical product or device).

E.5 End points

E.5.1

Primary end point(s)

Humoral immune response in terms of haemagglutinin inhibition (HI) antibody Global Mean Titres (GMT) to each strain of FLU D-QIV.

E.5.1.1

Timepoint(s) of evaluation of this end point

At pre-vaccination (Day 0) and 28 days after the last vaccine dose.

E.5.2

Secondary end point(s)

- Humoral immune response in terms of haemagglutinin inhibition (HI) antibody global mean titre (GMT), seropositivity, sero-conversion rate (SCR), seroconversion factor (SCF), and sero-protection rate (SPR), to each of the four vaccine strains
- Occurrence of solicited local and general symptoms
- Occurrence of unsolicited adverse events (AE)
- Occurrence of adverse events of specific interest (AESI), and serious adverse events (SAE)

E.5.2.1

Timepoint(s) of evaluation of this end point

- Humoral immune response: On Day 0 and 28 days after last vaccine dose
- Solicited local and general symptoms: during a 7-day follow-up period after dose 1 (at Day 0) or dose 2 (at Day 28)
- Unsolicited adverse events (AE): During a 28-day follow-up period (i.e., day of vaccination and 27 subsequent days)
- Adverse events of specific interest (AESI), and serious adverse events (SAE): During the entire study period (Day 0 to Day 180).

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

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

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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

Will this trial be conducted at a single site globally?

E.8.4

Will this trial be conducted at multiple sites globally?

Yes

E.8.6 Trial involving sites outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Yes

E.8.6.3

Specify the countries outside of the EEA in which trial sites are planned

Mexico

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

E.8.9 Initial estimate of the duration of the trial

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:

599

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:

299

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

300

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

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.4.2

For a multinational trial

F.4.2.2

In the whole clinical trial

600

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

H.4 Third Country in which the Trial was first authorised
H.4.1	Third Country in which the trial was first authorised:	Mexico

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