Clinical Trials Register

Summary
EudraCT Number:	2011-002410-36
Sponsor's Protocol Code Number:	115524
National Competent Authority:	Czechia - SUKL
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-05-16
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

Czechia - SUKL

A.2

EudraCT number

2011-002410-36

A.3

Full title of the trial

A phase III, open, controlled study to evaluate immunogenicity of GSK Biologicals’ MenACWY-TT conjugate vaccine administered intramuscularly to at risk subjects from 1 to less than 18 years and to an age-matched control group of healthy subjects

A.3.1

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

Immunogenicity and safety study of GSK Biologicals’ meningococcal vaccine GSK 134612 administered to at risk subjects from 1 to less than 18 years.

Hodnocení imunogenity a bezpečnosti meningokokové vakcíny GSK134612 společnosti GSK Biologicals u rizikových subjektů od 1 do 18 let.

A.3.2

Name or abbreviated title of the trial where available

MENACWY-TT-084

A.4.1

Sponsor's protocol code number

115524

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/278/2011

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	Yes
D.2.1.1.1	Trade name	Nimenrix
D.2.1.1.2	Name of the Marketing Authorisation holder	GlaxoSmithKline Biologicals
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Nimenrix
D.3.4	Pharmaceutical form	Powder and solvent for solution 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.3.9.2	Current sponsor code	MenA-TT
D.3.9.3	Other descriptive name	Meningococcal serogroup A polysaccharide conjugated to tetanus toxoid
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	5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	MenC-TT
D.3.9.3	Other descriptive name	Meningococcal serogroup C polysaccharide conjugated to tetanus toxoid
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	5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	MenW-TT
D.3.9.3	Other descriptive name	Meningococcal serogroup W polysaccharide conjugated to tetanus toxoid
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	5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	MenY-TT
D.3.9.3	Other descriptive name	Meningococcal serogroup Y polysaccharide conjugated to tetanus toxoid
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	5
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

Meningococcal infection

E.1.1.1

Medical condition in easily understood language

Bacterial meningitis (infection of fluid and cover surrounding the brain) and bacteremia (infection of the blood)

Meningitida (zánět mozkových blan) a bakterémie (infekce šířící se krví) způsobené meningokoky

E.1.1.2

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	15.1
E.1.2	Level	LLT
E.1.2	Classification code	10027275
E.1.2	Term	Meningococcal infection, unspecified
E.1.2	System Organ Class	100000004862

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the immunogenicity of 1 and 2 doses of GSK 134612 administered to at risk subjects compared to age-matched healthy subjects in terms of vaccine response rates to meningococcal antigens.

E.2.2

Secondary objectives of the trial

To evaluate the immunogenicity of 1 and 2 doses of GSK134612 administered to at risk subjects compared to age-matched healthy subjects
To evaluate the safety and reactogenicity of 1 and 2 doses of GSK 134612 administered to at risk subjects compared to age-matched healthy subjects in terms of solicited symptoms, unsolicited symptoms, serious adverse events (SAEs) and new onset of chronic illness (NOCIs)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol
• A male or female 1 to 17 years of age at the time of the first vaccination
• Written informed consent obtained from the parent(s)/LAR(s) of the subject and informed assent obtained from the subject, if appropriate, prior to enrolment.
• Female subjects of non-childbearing potential may be enrolled in the study.
• Female subjects of childbearing potential may be enrolled in the study, if
- the subject has practiced adequate contraception for one month (30 days) prior to the first vaccine dose, and
- has a negative pregnancy test on the day of vaccination, and
- has agreed to continue adequate contraception from administration of the first vaccine dose until 2 months after administration of the second vaccine dose.
Additional inclusion criterion for At-risk group
• Subjects with an increased risk for meningococcal disease, such as anatomic asplenia or some degree of functional asplenia or complement deficiencies.
Additional inclusion criteria for Healthy group
• Healthy subject as established by medical history and clinical examination before entering into the study.
• Age-matched to a subject from the At-risk group according to age strata 1-5 years, 6-10 years and 11 to 17 years.

E.4

Principal exclusion criteria

• Child in care
• Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period (until the phone contact at Month 8).
• Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days before administration of each study vaccine dose until 30 days after administration of each study vaccine dose. Administration of licensed inactivated influenza vaccines is allowed as per local recommendations
• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product
• History of meningococcal disease
• Any confirmed or suspected Human Immunodeficiency Virus (HIV) infection, based on medical history and physical examination
• Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine until one month after the second dose of study vaccine
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine including latex.
• Major congenital defects.
• History of any neurological disorders or seizures, including Guillain-Barré syndrome (GBS). History of a simple, single febrile seizure is permitted.
• Acute disease and/or fever at the time of enrolment
• Pregnant or lactating female
• History of chronic alcohol consumption and/or drug abuse
• Female planning to become pregnant or planning to discontinue contraceptive precautions
Additional exclusion criteria for the At-risk group
• Vaccination against meningococcal disease of any serogroup
- within the last 3 years for subjects younger than 7 years
- within the last 5 years for subjects 7 years and older.
Additional exclusion criteria for the Healthy group
• Vaccination against meningococcal disease of any serogroup with polysaccharide or conjugate vaccine within the last 5 years.
• Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose.
• Family history of congenital or hereditary immunodeficiency.
• Any confirmed or suspected immunosuppresive or immunodeficient condition.
• Serious chronic illness
• History of asplenia or hyposplenia or complement deficiencies

E.5 End points

E.5.1

Primary end point(s)

Immunogenicity with respect to components of the investigational vaccine in terms of vaccine response

E.5.1.1

Timepoint(s) of evaluation of this end point

One month after the first vaccine dose (at Month 1)
One month after the second vaccine dose (at Month 3)

E.5.2

Secondary end point(s)

1. Immunogenicity with respect to components of the investigational vaccine in terms of antibody titres and antibody concentrations
2. Occurrence of solicited local and general symptoms
3. Occurrence of unsolicited adverse events
4. Occurrence of serious adverse events
5. Occurrence of new onset of chronic illnesses

E.5.2.1

Timepoint(s) of evaluation of this end point

1. Just before and after the first vaccine dose and after the second vaccine dose (At Month 0, Month 1 and Month 3)
2. Within 4 days (Day 0 to Day 3) after each vaccine dose
3. Within 31 days (Day 0 to Day 30) after each vaccine dose
4. and 5. From the first dose until the end of the extended safety follow-up period (From Month 0 up to Month 8)

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

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)

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

E.8.1.2

Open

Yes

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

Yes

E.8.2.3.1

Comparator description

different population

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

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

United States

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

Phone contact at Month 8
The subjects' parents/legally acceptable representatives are contacted by phone 6 months after the second vaccine dose for a follow-up on safety information. This phone call is considered the end of the trial.

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