Clinical Trials Register

Summary
EudraCT Number:	2012-001230-34
Sponsor's Protocol Code Number:	116023
National Competent Authority:	Poland - Office for Medicinal Products
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-09-10
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

Poland - Office for Medicinal Products

A.2

EudraCT number

2012-001230-34

A.3

Full title of the trial

A phase III, open-label, multicentre study to evaluate the immunogenicity, safety and reactogenicity of a revaccination dose of the GlaxoSmithKline Biologicals' quadrivalent seasonal influenza candidate vaccine GSK2321138A, administered to children who previously participated in study 115345 (FLU D-QIV-004 PRI).

„Prowadzone metodą otwartej próby, wieloośrodkowe badanie fazy III mające na celu ocenę immunogenności, bezpieczeństwa i reaktogenności dawki przypominającej czterowalentnej sezonowej szczepionki przeciwko grypie GSK2321138A firmy GlaxoSmithKline Biologicals, podanej dzieciom, które uczestniczyły wcześniej w badaniu 115345 (FLU D-QIV-004 PRI).”

A.3.1

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

Immunogenicity and safety study of GlaxoSmithKline (GSK) Biologicals’ influenza vaccine when administered in children who previously participated in study 115345

A.3.2

Name or abbreviated title of the trial where available

FLU D-QIV-009 EXT 004

A.4.1

Sponsor's protocol code number

116023

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/817/2011

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	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	GlaxoSmithKline (GSK) Biologicals’ quadrivalent seasonal influenza vaccine Flu-D-QIV
D.3.2	Product code	GSK2321138A
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	Split virion, inactivated
D.3.9.3	Other descriptive name	A/CALIFORNIA/7/2009 (H1N1)V-LIKE VIRUS
D.3.9.4	EV Substance Code	SUB30545
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	Split virion, inactivated
D.3.9.3	Other descriptive name	A/Victoria/361/2011 (H3N2)-like virus
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	Split virion, inactivated
D.3.9.3	Other descriptive name	B/BRISBANE/60/2008 (Victoria lineage)-LIKE VIRUS
D.3.9.4	EV Substance Code	SUB30542
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	Split virion, inactivated
D.3.9.3	Other descriptive name	B/Wisconsin/1/2010 (Yamagata lineage)-like virus
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.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 (Immunization against influenza A and B in children aged 18 to 47 months)

E.1.1.1

Medical condition in easily understood language

seasonal flu

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	15.0
E.1.2	Level	LLT
E.1.2	Classification code	10022002
E.1.2	Term	Influenza A virus infection
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.2 Medical condition or disease under investigation

E.1.2	Version	15.0
E.1.2	Level	LLT
E.1.2	Classification code	10022001
E.1.2	Term	Influenza (epidemic)
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.2 Medical condition or disease under investigation

E.1.2	Version	15.0
E.1.2	Level	LLT
E.1.2	Classification code	10022003
E.1.2	Term	Influenza B virus infection
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.2 Medical condition or disease under investigation

E.1.2	Version	15.0
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

To assess the immune response in terms of Haemagglutination Inhibition (HI) antibody titre at Day 7 after one dose of FLU D-QIV vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all strains included in the vaccine.

E.2.2

Secondary objectives of the trial

•To assess the Geometric Mean Titre (GMT) ratio of primed to unprimed subjects, at Day 7 after one dose of FLU D-QIV vaccine.
•To assess the difference in Seroconversion rate (SCR) between primed and unprimed subjects, at Day 7 after one dose of FLU D-QIV vaccine.
•To assess the difference in Seroprotection rate (SPR) between primed and unprimed subjects, at Day 7 after one dose of FLU D-QIV vaccine.
•To categorize the risk profile by assessing the percentage of subjects with HI antibody titres < 1:10, 1:10 to < 1:40, and ≥1:40 at Day 0 (prior to vaccination) and at Day 7 after one dose of FLU D-QIV vaccine.
•To assess the immune response in terms of neutralising and anti-neuraminidase (AN) antibody responses.
•To assess the immune response by age group (17 to 29 and 30 to 48 months old).
•To assess the safety of the study vaccine during the entire study period and the reactogenicity of the study vaccine after the first dose.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

•Subjects who the investigator believes that parent(s)/LAR(s) can and will comply with the requirements of the protocol.
•Children, male or female who received a 2-dose vaccination in the study 115345 (NCT01439360).
•Written informed consent obtained from the parent(s)/LAR(s) of the subject.
•Subjects in stable health as determined by medical history and clinical examination before entering into the study.

E.4

Principal exclusion criteria

•Child in care
•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.
•Since the start of study 115345 (NCT01439360), receipt of any seasonal influenza vaccine other than the study vaccines of study 115345 or planned administration of any influenza vaccine other than the study vaccine during the study.
•Administration of any vaccine not foreseen by the study protocol within 4 weeks preceding the first dose of study vaccine or planned use until Visit 2.
•Laboratory confirmed influenza infection outside of the 115345 (NCT01439360) study.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to enrolment in the study or planned administration during the study period. Inhaled and topical steroids are allowed.
•Administration of immunoglobulins and/ or any blood products within 3 months preceding the first dose of study vaccine or planned administration during the study period.
•History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
•Any contraindication to intramuscular injection.
•Acute disease and/or fever at the time of enrolment:
- Fever is defined as temperature ≥ 37.5°C by any route.
- Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
•Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.

E.5 End points

E.5.1

Primary end point(s)

Serum Hemagglutination Inhibition (HI) antibody titres against each of the vaccine strains after 1 dose of FLU D-QIV vaccine.
•Seropositivity rates at Days 0.
•GMTs of HI antibody titres
•SCR*
•SPR**
•Mean Geometric Increase (MGI)***
*SCR is defined as the percentage of vaccinees that have either a pre-vaccination titre<1:10 and a post-vaccination titre >= 1:40 or a pre-vaccination titre >= 1:10 and at least a four-fold increase in post-vaccination titre.
**SPR is defined as the percentage of vaccinees with a serum HI titre >= 1:40 that usually is accepted as indicating protection in adults.
***MGI is defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination.

E.5.1.1

Timepoint(s) of evaluation of this end point

Seropositivity rates, GMTs of HI antibody titres and SPR at Day 0.
Seropositivity rates, GMTs of HI antibody titres, SCR, MGI and SPR at Day 7.

E.5.2

Secondary end point(s)

Serum HI antibody titres against each of the vaccine strains after 1 dose of FLU D-QIV vaccine:
•GMTs ratios of primed versus unprimed subjects
•SCR difference between primed and unprimed subjects
•SPR difference between primed and unprimed subjects
•Percentage of subjects with HI antibody titres < 1:10, 1:10 to < 1:40 and ≥ 1:40
Serum neutralising antibody titres and anti-neuraminidase antibody titres against each of the vaccine strains after 1 dose of FLU D-QIV vaccine:
•GMTs
•Vaccine Response Rates (VRRs)*
•MGIs**
For neutralising antibodies:
* VRR is defined as the percentage of vaccinees who have at least a 4-fold increase between pre and post-vaccination titres.
** MGI is defined as the fold increase in GMTs post-vaccination compared to Day
Occurrence of solicited local and general adverse events (AEs).
Occurrence of unsolicited AEs.
Occurrence of AEs with Medically Attended Visits (MAV).
Occurrence of serious adverse events (SAEs) and potential immune mediated diseases (pIMDs).

E.5.2.1

Timepoint(s) of evaluation of this end point

Serum HI antibody titres, serum neutralising antibody titres and anti-neuraminidase antibody titres at Day 0 and Day 7.
Occurrence of solicited local and general AEs during a 7-day (Day 0 to 6) follow-up period after the first vaccination.
Occurrence of unsolicited AEs Within 28 days after first vaccination (Day 0 – Day 27).
Occurrence of AEs with MAV, of SAEs and pIMDs during the entire study period (Day 0 – 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

Yes

E.6.13.1

Other scope of the trial description

immunogenicity

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

E.8.1.1

Randomised

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

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.8.5

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

Primary epoch starting at Visit 1 (Day 0) and ending at contact (Day 180).

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:

452

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:

113

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

339

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.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

452

F.4.2.2

In the whole clinical trial

452

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)

A plan for treatment or care after the subject has ended the participation in this trial is not provided for prophylactic vaccine studies as the subjects are healthy and do not need any treatment or care after end of the study.

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

2012-11-05

Ethics Committee Opinion of the trial application

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2013-06-05

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