Clinical Trials Register

Summary
EudraCT Number:	2012-002719-24
Sponsor's Protocol Code Number:	112021
Clinical Trial Type:	Outside EU/EEA
Date on which this record was first entered in the EudraCT database:	2015-06-01
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

2012-002719-24

A.3

Full title of the trial

A phase II, open, multi-center study to evaluate the long-term anti-body persistence at 1 year, 3 years and 5 years after the administration of one or two doses of GlaxoSmithKline (GSK) Biologicals’ meningococcal serogroups A, C, W-135, Y-tetanus toxoid conjugate (MenACWY-TT) vaccine in healthy toddlers at 9-12 months of age, and to evaluate the safety and immunogenicity of a booster dose of MenACWY-TT administered 5 years post-primary vaccination and of a primary vaccination of MenACWY-TT in a newly enrolled group, aged 5-6 years, as a naïve control.

A.3.1

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

The long-term antibody persistence of GSK Biologicals’ meningococcal vaccine GSK134612 in healthy toddlers

A.3.2

Name or abbreviated title of the trial where available

MENACWY-TT-062 EXT:055 Y1, 3, 5

A.4.1

Sponsor's protocol code number

112021

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 I'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	GSKClinicalSupport@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.3.2	Product code	MenACWY-TT
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.3.8	INN - Proposed INN	-
D.3.9.2	Current sponsor code	MenA-TT
D.3.9.3	Other descriptive name	NEISSERIA MENINGITIDIS GROUP A POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
D.3.9.4	EV Substance Code	SUB36479
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.3.8	INN - Proposed INN	-
D.3.9.2	Current sponsor code	MenC-TT
D.3.9.3	Other descriptive name	N. MENINGITIDIS GROUP C (STRAIN C11) POLYSACCHARIDE (DE-O-ACETYLATED) CONJUGATED TO TETANUS TOXOID
D.3.9.4	EV Substance Code	SUB26116
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.3.8	INN - Proposed INN	-
D.3.9.2	Current sponsor code	MenW-135-TT
D.3.9.3	Other descriptive name	NEISSERIA MENINGITIDIS GROUP W-135 POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
D.3.9.4	EV Substance Code	SUB36481
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.3.8	INN - Proposed INN	-
D.3.9.2	Current sponsor code	MenY-TT
D.3.9.3	Other descriptive name	NEISSERIA MENINGITIDIS GROUP Y POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
D.3.9.4	EV Substance Code	SUB36482
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

Invasive disease caused by Neisseria meningitidis serogroups A, C W-135 and Y

E.1.1.1

Medical condition in easily understood language

Inflammation of the brain and infection of the blood

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	18.0
E.1.2	Level	LLT
E.1.2	Classification code	10028910
E.1.2	Term	Neisseria meningitides meningitis
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	LLT
E.1.2	Classification code	10028911
E.1.2	Term	Neisseria meningitidis infection NOS
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 long-term persistence of the immunogenicity induced by one or two doses of MenACWY-TT vaccine administered at 12 months or 9 and 12 months of age in terms of the percentage of subjects with N. meningitidis serogroup A (MenA), N. meningitidis serogroup C (MenC), N. meningitidis serogroup W-135 (MenW-135), and N. meningitidis serogroup Y (MenY) antibody titers >= 1:8 as measured by a serum bactericidal assay using human complement (hSBA).

E.2.2

Secondary objectives of the trial

•long-term persistence of MenACWY-TT in all subjects with respect to the percentage of subjects with hSBA-MenA/C/W-135/Y titers ≥ 1:4 and GMTs and rSBA-MenA/C/W-135/Y titers. at Years 1, 3 and 5
•long-term persistence of MenACWY-TT vaccine in all subjects with respect to ELISA at Year 1 only.
One month post-booster and post-primary (naïve control group) vaccination with MenACWY-TT.
•immunogenicity of a booster and a primary vaccination of MenACWY-TT with respect to the percent of subjects with hSBA-MenA/C/W-135/Y titers ≥ 1:4, ≥ 1:8 and GMTs and rSBA-MenA/C/W-135/Y titers.
•immunogenicity of a booster and a primary vaccination of MenACWY-TT with respect to the percentage of subjects with hSBA-MenA/C/W-135/Y and rSBA-MenA/C/W-135/Y vaccine response
•To evaluate the safety of MenACWY-TT with respect to:
-Local and general solicited symptoms
-Unsolicited serious and non-serious adverse events
-Serious adverse events and new onset of chronic illness(es)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

All subjects must satisfy the following criteria for the per-sistence phase of the study entry:
•A male or female toddler who was vaccinated 1, 3 or 5 years ago with the last dose of MenACWY-TT in study with NCT number=00471081.
•Written informed consent obtained from parents/guardian of the subject.
•Healthy subjects as established by medical history before entering into the study.
•Having completed the active phase of the vaccination study with NCT number=00471081 (i.e., not withdrawn, had received all planned doses of study vaccines, provided a post-vaccination blood sample after the final dose).
All subjects must meet the following criteria prior to receiving the booster vaccination:
•Written informed consent obtained from parents/guardian of the subject.
•Subjects who can and will comply with the requirements of the protocol.
•Subjects who provide a blood sample 5 years after last vaccination in study with NCT number=00471081.

E.4

Principal exclusion criteria

Exclusion criteria for persistence study entry
•Use of any investigational or non-registered product (drug or vaccine) within 30 days of each persistence timepoint.
•Vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, B, C, W-135, and/or Y outside of study with NCT number=00471081.
•History of any meningococcal disease due to serogroup A, B, C, W-135, or Y.
•Any confirmed or suspected immunosuppressive or im-munodeficiency condition based on medical history and physical examination (no laboratory testing is required).
•Administration of immunoglobulins and/or any blood products within the three months preceding each persistence timepoint.
•Concurrently participating in another clinical study within 30 days of each persistence timepoint, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
•Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
•Subjects withdrew consent to be contacted for follow-up studies.
Exclusion criteria for booster vaccination at year 5 study entry (to be checked at Year 5)
•Subjects who were enrolled in the Kaiser Healthcare system in study with NCT number=00471081, but are no longer enrolled.
•Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the booster vaccina-tion, or planned use during the study period.
•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccination. (For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
•Vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, B, C, W-135, and/or Y outside of study with NCT number=00471081.
•History of any meningococcal disease due to serogroup A, B, C, W-135, or Y.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history (no laboratory testing is required).
•Administration of immunoglobulins and/or any blood products within the three months preceding the booster vaccination or planned administration during the study period.
•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 (pharmaceutical product or device).
•Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
•Subjects withdrew consent to be contacted for follow-up studies.
•Hypersensitivity to latex.
•Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine(s) with the exception of any licensed inactivated influenza vaccine (live attenuated influenza vaccine is not allowed).
•Previous vaccination with tetanus and diphtheria toxoids within the last month (i.e., Tdap, Td, and TT-containing vaccine).
•A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
•Major congenital defects or serious chronic illness.
•History of any neurological disorders or seizures.
•Acute disease at the time of vaccination. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e., temperature by any method < 99.5°F (37.5°C).

E.5 End points

E.5.1

Primary end point(s)

Meningococcal hSBA antibody titers

E.5.1.1

Timepoint(s) of evaluation of this end point

One year, three years, and five years after primary vaccination

E.5.2

Secondary end point(s)

Meningococcal hSBA antibody titers
Meningococcal rSBA antibody titers
Meningococcal ELISA concentrations
Meningococcal hSBA and rSBA vaccine response
Occurrence of solicited local and general symptoms
Occurrence of non-serious adverse events
Occurrence of serious adverse events an new onset chronic illness(es)

E.5.2.1

Timepoint(s) of evaluation of this end point

One month post booster vaccination with GSK134612 vaccine at year 5 after primary vaccination and one month post-primary vaccination in newly enrolled
One year, three years, and five years after primary vaccination and one month post booster vaccination with GSK134612 vaccine at year 5 after primary vaccination and one month post-primary vaccination in newly enrolled
One year after primary vaccination
one month post booster vaccination with GSK134612 vaccine at year 5 after primary vaccination and one month post-primary vaccination in newly enrolled
4 days following vaccination
31 days following vaccination
6 months following 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

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Treatment groups

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

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

LSLV

E.8.9 Initial estimate of the duration of the trial

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:

387

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)

Yes

F.1.1.5.1

Number of subjects for this age range:

387

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

372

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:	United States

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