Clinical Trials Register

Summary
EudraCT Number:	2012-002737-11
Sponsor's Protocol Code Number:	116705
National Competent Authority:	Germany - PEI
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-10-05
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

Germany - PEI

A.2

EudraCT number

2012-002737-11

A.3

Full title of the trial

A Phase III, randomised, partially-blind, controlled, multi-centric, multi-country study to evaluate the immunogenicity, safety and reactogenicity of GSK Biologicals’ MenACWY-TT conjugate vaccine co-administered with Boostrix® administered intramuscularly versus MenACWY-TT alone administered intramuscularly, in healthy adolescents and young adults between 11 and 25 years of age.

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’ meningococcal conjugate vaccine (GSK134612) when co-administered with Boostrix® in subjects between 11 and 25 years of age.

A.3.2

Name or abbreviated title of the trial where available

MENACWY-TT-098

A.4.1

Sponsor's protocol code number

116705

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 S.A.
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.3.10	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.3.10	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.3.10	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.3.10	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.IMP: 2
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	Boostrix
D.2.1.1.2	Name of the Marketing Authorisation holder	GlaxoSmithKline GmbH & Co. KG
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.3.1	Product name	Boostrix
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	Purified diphtheria toxoid
D.3.9.2	Current sponsor code	D
D.3.9.3	Other descriptive name	Purified diphtheria toxoid
D.3.10	Strength
D.3.10.1	Concentration unit	LfU lime flocculation unit(s)
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	2.5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Purified tetanus toxoid
D.3.9.2	Current sponsor code	T
D.3.9.3	Other descriptive name	Purified tetanus toxoid
D.3.10	Strength
D.3.10.1	Concentration unit	LfU lime flocculation unit(s)
D.3.10.2	Concentration type	not less then
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	Purified Pertussis toxoid
D.3.9.2	Current sponsor code	PT
D.3.9.3	Other descriptive name	Purified Pertussis 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	8
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Purified filamentous Haemagglutin
D.3.9.2	Current sponsor code	FHA
D.3.9.3	Other descriptive name	Purified filamentous Haemagglutin
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	8
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Purified Pertactin
D.3.9.2	Current sponsor code	PRN
D.3.9.3	Other descriptive name	Purified Pertactin
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	2.5
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 disease

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	14.1
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	14.1
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

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

•To demonstrate the non-inferiority of MenACWY-TT co-administered with Boostrix® compared to MenACWY-TT administered alone with respect to serum bactericidal assay using rabbit complement (rSBA) geometric mean titres (GMTs) for serogroups A, C, W-135 and Y one month after MenACWY-TT vaccination.
•To demonstrate the non-inferiority of Boostrix® co-administered with MenACWY-TT compared to Boostrix® administered alone in terms of anti-diphtheria toxoid (anti-D) and anti-tetanus toxoid (anti-T) antibody concentrations one month after Boostrix® vaccination.
•To demonstrate the non-inferiority of Boostrix® co-administered with MenACWY-TT compared to Boostrix® administered alone with respect to geometric mean concentrations (GMCs) to each discrete pertussis antigen (pertussis toxoid [PT], filamentous haemagglutinin [FHA] and pertactin [PRN]) one month after Boostrix® vaccination.

E.2.2

Secondary objectives of the trial

•To evaluate the immunogenicity of MenACWY-TT co-administered with Boostrix® or administered alone in all three study groups with respect to (1) the percentage of subjects with rSBA titres ≥ 1:8, ≥ 1:128 prior to and one month after MenACWY-TT vaccination, and (2) the vaccine response one month after MenACWY-TT vaccination.
•To evaluate the immunogenicity of Boostrix® co-administered with MenACWY-TT compared to Boostrix® administered alone with respect to (1) anti-D and anti-T GMCs, and (2) a booster response to PT, FHA and PRN one month after Boostrix® vaccination in all three study groups.
•To compare the immunogenicity of MenACWY-TT given one month after Boostrix® to MenACWY-TT given one month before Boostrix® and vice versa.
•To evaluate the safety and reactogenicity after vaccination with MenACWY-TT and Boostrix® in terms of solicited symptoms, unsolicited symptoms, serious adverse events and new onset of chronic illnesses throughout the study following each vaccination.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

•Healthy subjects as established by medical history and clinical examination before entering into the study.
•Subjects and 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, 11 and 25 years of age at the time of the first vaccination.
•Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the subject.
•Written informed assent obtained from the subjects when applicable according to local regulations.
•Female subjects of non-childbearing potential may be enrolled in the study.
•Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy or ovariectomy.
•Female subjects of childbearing potential 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 other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
•Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone ≥ 10 mg/day, 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 the first dose of vaccine and ending 30 days after the last dose of vaccine, with the exception of 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 product.
•Previous vaccination with a meningococcal vaccine.
•History of meningococcal disease.
•Vaccination with a DTP-containing vaccine within the previous five years.
•History of serious allergic reaction following any other DTP-containing vaccine or any component of the study vaccines.
•History of encephalopathy within seven days following administration of a previous dose of pertussis vaccine that is not attributable to another identifiable cause.
•Temperature of ≥ 40.5°C (105°F) within 48 hours of receipt of a previous dose of DTP vaccine, not due to another identifiable cause.
•Collapse or shock-like state within 48 hours of receipt of a previous dose of DTP vaccine.
•Seizures with or without fever within three days of a previous dose of DTP vaccine.
•Severe Arthus-type hypersensitivity reactions following a prior dose of tetanus toxoid (TT) within the previous ten years.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination during the study period.
•History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
•Progressive neurologic disorder, uncontrolled epilepsy or progressive encephalopathy.
•History of any neurologic disorders or seizures, including Guillain-Barré syndrome (GBS). History of a simple, single febrile seizure is permitted.
•Bleeding disorders, such as haemophilia or thrombocytopenia, or subjects on anticoagulant therapy.
•Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine, or planned administration during the study period.
•Pregnant or lactating female.
•Female planning to become pregnant or planning to discontinue contraceptive precautions.
•Family history of congenital or hereditary immunodeficiency.
•Major congenital defects or serious chronic illness.
•Acute disease and/or fever at the time of enrolment.
-Fever is defined as temperature ≥ 37.5°C /99.5°F for oral, axillary or tympanic 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.

E.5 End points

E.5.1

Primary end point(s)

1)rSBA-MenA, rSBA-MenC, rSBA -MenW-135 and rSBA-MenY GMTs
2)Anti-D and anti-T concentrations ≥1.0 IU/mL
Anti-PT, anti-FHA and anti-PRN GMCs.

E.5.1.1

Timepoint(s) of evaluation of this end point

1)One month after MenACWY-TT vaccination in the Co-ad and ACWYTdap groups
2)One month after Boostrix® vaccination in the Co-ad and TdapACWY groups

E.5.2

Secondary end point(s)

1)rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titres ≥ 1:8 and ≥ 1:128
2)rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY GMTs
3)rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY vaccine response
4)Anti-D and anti-T concentrations ≥1.0 IU/mL
5)Anti-D GMCs and seroprotection rates.
6)Anti-T GMCs and seroprotection rates
7)Anti-PT, anti-FHA and anti-PRN concentrations ≥ 5.0 EL/mL
8)Anti-PT, anti-FHA and anti-PRN GMCs
9)Booster responses for anti-PT, anti-FHA and anti-PRN concentrations
10)Occurrence of NOCIs (asthma, autoimmune disorders, type 1 diabetes and allergies)

E.5.2.1

Timepoint(s) of evaluation of this end point

1)Prior to and one month after MenACWY-TT vaccination in all study groups
2)Prior to and one month after MenACWY-TT vaccination in the TdapACWY group
3)One month after MenACWY-TT vaccination in all study groups
4)One month after Boostrix® vaccination in the ACWYTdap group
5)Prior to and one month after Boostrix® vaccination
6)All time points in all study groups
7)Prior to and one month after Boostrix® vaccination in all study groups
8)One month after Boostrix® vaccination in the ACWYTdap group
9)One month after Boostrix® vaccination in all study groups
10)Throughout the study (Month 0 – Month 2)

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

Yes

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, reactogenicity

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

Yes

E.8.1.2

Open

E.8.1.3

Single blind

Yes

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 treatment schedule

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

Dominican Republic

Korea, Democratic People's Republic of

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:

345

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)

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

345

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

345

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

180

F.4.2

For a multinational trial

F.4.2.1

In the EEA

180

F.4.2.2

In the whole clinical trial

690

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
“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

2012-12-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-12-04

P. End of Trial
P.	End of Trial Status	Completed

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IMP with orphan designation in the indication
Orphan Designation Number:
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