Clinical Trials Register

Summary
EudraCT Number:	2013-004778-84
Sponsor's Protocol Code Number:	116775
National Competent Authority:	Sweden - MPA
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2014-01-16
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

Sweden - MPA

A.2

EudraCT number

2013-004778-84

A.3

Full title of the trial

A Phase IIIb, open-label, multi-centric study to evaluate the immunogenicity of one dose of GSK Biologicals’ MenACWY-TT conjugate vaccine administered intramuscularly in healthy adolescents aged 10 to 15 years, previously primed with a MenC conjugate vaccine.

A.3.1

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

Immunogenicity and safety study of one dose of GSK Biologicals’ meningococcal conjugate vaccine (GSK134612) in healthy adolescents aged 10 to 15 years.

A.3.2

Name or abbreviated title of the trial where available

MENACWY-TT-089

A.4.1

Sponsor's protocol code number

116775

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	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.3.8	INN - Proposed INN	Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid carrier protein
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	Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid carrier protein
D.3.9.2	Current sponsor code	MenC-TT
D.3.9.3	Other descriptive name	Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid carrier protein
D.3.9.4	EV Substance Code	SUB36480
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	Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid carrier protein
D.3.9.2	Current sponsor code	MenW-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	Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid carrier protein
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

Healthy subjects (active immunisation of individuals from the age of 12 months against invasive meningococcal diseases caused by Neisseria meningitidis serogroup 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	16.1
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.1.2 Medical condition or disease under investigation

E.1.2	Version	16.1
E.1.2	Level	LLT
E.1.2	Classification code	10070124
E.1.2	Term	Neisseria meningitidis test positive
E.1.2	System Organ Class	100000004848

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 evaluate the vaccine response induced by one dose of MenACWY-TT administered to MenC-primed and MenC unprimed subjects.

E.2.2

Secondary objectives of the trial

To evaluate the immunogenicity of a booster vaccination in MenC-primed subjects and immunogenicity of MenACWY-TT vaccination in unprimed subjects with respect to the percentage of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibody titres ≥ 1:4, ≥ 1:8 and GMTs.
To evaluate the immunogenicity of MenACWY-TT vaccination in terms of percentage of subjects with anti-TT concentrations ≥ 0.1 IU/mL, ≥ 1.0 IU/mL and geometric mean concentrations (GMCs).
To evaluate the safety and reactogenicity of one dose of the MenACWY-TT conjugate vaccine in terms of solicited symptoms, unsolicited symptoms, serious adverse events (SAEs) and new onset of chronic illnesses (NOCIs).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Subjects' 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 between, and including, 10 and 15 years of age at the time of vaccination.
• For the MenC-TT group, a subject who has been vaccinated with a MenC-TT conjugate vaccine in infancy and/or at toddler age (i.e., according to schedule 3+1, 2+1, 1+1, 1), and for whom vaccination is documented.
• For the MenC-CRM group, a subject who has been vaccinated with a MenC-CRM conjugate vaccine in infancy and/or at toddler age (i.e., according to schedule 3+1, 2+1, 1+1, 1), and for whom vaccination is documented.
• For the noMenC group, a subject who has not previously received any dose of MenC vaccine per documentation.
• Written informed consent obtained from the subject/subject’s parent(s)/LAR(s) as applicable according to local regulations.
• Written informed assent obtained from the subjects when applicable according to local regulations.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• For female subjects of non-childbearing potential:
These subjects may be enrolled in the study.
- In this study, non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy or ovariectomy.
• For female subjects of childbearing potential:
These subjects may be enrolled in the study, if the subject:
- has practiced adequate contraception for 30 days prior to vaccination, and
- has a negative pregnancy test on the day of vaccination, and
- has agreed to continue adequate contraception during the entire treatment period and for two months after completion of the vaccination series

E.4

Principal exclusion criteria

• Child in care
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
• Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. (For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day with an upper limit of 10 mg/kg or equivalent. Inhaled and topical steroids are allowed.)
• Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after the dose of vaccine (i.e., after blood sampling Visit 2), with the exception of a licensed inactivated influenza vaccine.
• 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 vaccine/product (pharmaceutical product or device).
• Previous vaccination against N. meningitidis with the exception of MenC vaccine for the MenC-TT and MenC-CRM groups.
• For the MenC-TT and MenC-CRM groups, vaccination against N. meningitidis serogroup C after two years of age.
• For the noMenC group, previous vaccination with any meningococcal vaccine.
• Previous vaccination with any TT-containing vaccine within 30 days prior to the first visit.
• History of, or intercurrent, meningococcal disease.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
• Family history of congenital or hereditary immunodeficiency.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
• Major congenital defects or serious chronic illness.
• 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.
- Fever is defined as temperature >=37.5°C for oral, axillary or tympanic route, or >= 38.0°C on rectal route. The preferred route for recording temperature in this study will be axillary. The oral route is also allowed.
- Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever, may be enrolled at the discretion of the investigator
• Administration of immunoglobulins and/or any blood products within the three months preceding the study vaccination or planned administration during the study period.
• History of chronic alcohol consumption and/or drug abuse.
• Anaphylaxis following the administration of vaccine(s).
• Pregnant or lactating female.
• Female planning to become pregnant or planning to discontinue contraceptive precautions.

E.5 End points

E.5.1

Primary end point(s)

Immunogenicity with respect to the components of the investigational vaccine
- hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY vaccine response

E.5.1.1

Timepoint(s) of evaluation of this end point

One month after vaccination with MenACWY-TT

E.5.2

Secondary end point(s)

1) Immunogenicity with respect to the components of the investigational vaccine
- hSBA-MenA, hSBA-MenC, hSBA-MenW-135 an hSBA-MenY antibody titres ≥ 1:4, ≥ 1:8 and GMTs.
- Anti-TT concentrations ≥ 0.1 IU/mL, ≥ 1.0 IU/mL and concentrations.
2) Solicited local and general symptoms
- Occurrence of each solicited local symptoms
- Occurrence of each solicited general symptoms
3) Unsolicited AEs
- Occurrence of unsolicited AEs according to the Medical Dictionary for Regulatory Activities (MedDRA) classification.
4) SAEs
- Occurrence of SAEs
5) New onset of chronic illness (NOCIs)
- Occurrence of NOCI(s) (e.g. asthma, autoimmune disorders, type I diabetes, and allergies)

E.5.2.1

Timepoint(s) of evaluation of this end point

1) Immunogenicity: Pre- and one month after vaccination with MenACWY-TT
2) Solicited local and general symptoms : Within 4 days (Days 0-3) after vaccination
3) Unsolicited AEs: Within 31 days (Days 0-30) after vaccination
4) SAEs: From study vaccine administration up to 6 months post study vaccination
5) New onset of chronic illness (NOCIs): From study vaccine administration up to 6 months post study 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

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

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

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

Active control (noMenC group)

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

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

LVLS

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:

600

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:

200

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

400

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

Yes

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

200

F.4.2

For a multinational trial

F.4.2.1

In the EEA

600

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)

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

2014-03-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-02-14

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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