Clinical Trials Register

Summary
EudraCT Number:	2010-018730-51
Sponsor's Protocol Code Number:	113977
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:	2010-10-06
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

2010-018730-51

A.3

Full title of the trial

A phase IIIb, open, multi-centre, controlled study to assess the long-term persistence of antibodies after a single dose of GlaxoSmithKline (GSK) Biologicals’ meningococcal serogroup ACWY tetanus-toxoid conjugate vaccine (MenACWY-TT) versus one dose of Novartis’ meningococcal serogroup C CRM197 conjugate vaccine (Menjugate®) administered in healthy subjects aged 2 through 10 years in study
MENACWY-TT-081 PRI (111414) and to evaluate the safety and immunogenicity of a booster dose of MenACWY-TT, administered 68 months post-primary vaccination.

A.3.2

Name or abbreviated title of the trial where available

MENACWY-TT-088 EXT:081 M32, 44, 56, 68

A.4.1

Sponsor's protocol code number

113977

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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	Meningococcal serogroup A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine
D.3.2	Product code	GSK 134612
D.3.4	Pharmaceutical form	Powder and solvent for suspension for injection
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	Meningococcal serogroup A polysaccharide conjugated to tetanus toxoid
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	Meningococcal serogroup C polysaccharide conjugated to tetanus toxoid
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	Meningococcal serogroup W polysaccharide conjugated to tetanus toxoid
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	Meningococcal serogroup Y polysaccharide conjugated to tetanus toxoid
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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

Vaccination of children 2 to 10 years of age against invasive disease caused by meningococcal serogroups A, C, W-135, and Y.

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	PT
E.1.2	Classification code	10027274
E.1.2	Term	Meningococcal infection
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

Immunogenicity
Persistence
At 32, 44, 56 and 68 months after primary vaccination with MenACWY-TT or Menjugate.
•To evaluate the persistence of meningococcal antibodies in terms of the percentage of subjects with rSBAMenA,
rSBA-MenC, rSBA-MenW-135, rSBA-MenY titres ≥1:8.

E.2.2

Secondary objectives of the trial

Immunogenicity at 32, 44, 56 and 68 months after primary vaccination
in terms of
•rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥1:128 and GMTs;
•hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY titres ≥1:4, ≥1:8 and GMTs.
Immunogenicity at one month post-booster with MenACWY-TT in terms of
•rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titres ≥1:8, ≥1:128, GMTs and rSBA vaccine response;
•hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibody titres ≥1:4, ≥1:8, GMTs and hSBA vaccine response.
Evaluate safety on Days 0-3 following the booster vaccination
•Occurrence of each solicited local and general symptom.
Evaluate safety on Days 0-30 following the booster vaccination
•Occurrence of unsolicited AEs, SAEs and new onset of chronic illness.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

All subjects must satisfy ALL the following criteria at study entry:
•Subjects who the investigator believes that their parent(s)/LAR(s) can and will comply with the requirements of the protocol (e.g. return for follow-up visits) should be enrolled in the study.
•A male or female who was primed with MenACWY-TT or Menjugate in the primary vaccination study MENACWY-TT-081 PRI (111414).
•Written informed consent obtained from the parent(s)/LAR(s) of the subject and written informed assent obtained from the subject (at investigator discretion).
•Healthy subjects as established by medical history and clinical examination before entering into the study.
All subjects must meet the additional following criteria prior to receiving the booster vaccination:
•Subjects who had a blood sample taken at Visit 4 during the persistence epoch of the current study.
•Female subjects of non-childbearing potential may be enrolled in the study.
- Non-childbearing potential is defined as pre-menarche (absence of menses).
•Female subjects of childbearing potential may be enrolled in the study, if the subject:
- has practiced adequate contraception (including abstinence) for 30 days prior to vaccination, and
- has a negative pregnancy test on the day of vaccination, and
- has agreed to continue adequate contraception (including abstinence) during the entire treatment period and for 2 months after completion of the vaccination series.

E.4

Principal exclusion criteria

Persistence and Booster
•Child in care.
•Use of any investigational or non-registered product (drug or vaccine)
•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs. (For corticosteroids, prednisone <10 mg/day, or equivalent, inhaled and topical steroids are allowed).
•Concurrently participating in another clinical study or planned participation in another clinical study, at any time during the study period (from the time of the booster until the end of the study), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
•History of meningococcal disease
•Vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, B, C, W-135, and/or Y since the previous vaccination in the primary vaccination study
•Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing is required).
•Serious chronic illness
•Administration of immunoglobulins and/or any blood products
•Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
•Subjects in contact with somebody suffering from an invasive infection with meningococcal serogroups A, C, Y or W-135.
•Subjects living in a geographic area where local outbreak with meningococcal serogroup C has occurred and would thus be likely to participate in a vaccination campaign against meningococcal serogroup C.
Booster only:
•Hypersensitivity to latex.
•Planned administration/ administration of a vaccine not foreseen by the study protocol within the last 30 days of the dose of vaccine(s) with the exception of a licensed inactivated influenza vaccine.
•Previous vaccination with tetanus toxoids within the last 30 days (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.
•History of any neurological disorders or seizures (although subjects with a prior history of a single episode of benign febrile seizures may be allowed to participate in the study).
•Acute disease and/or fever at the time of vaccination.
-Fever is defined as rectal temperature ≥38°C / axillary temperature ≥37.5°C / oral temperature of ≥37.5°C / tympanic temperature on oral setting ≥37.5°C.
-Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
•History of chronic alcohol consumption and/or drug abuse.
•History of hypotonic-hyporesponsive episodes (HHEs) following vaccination.
•Pregnant or lactating female.
•Female of child-bearing potential planning to become pregnant or planning to discontinue contraceptive precautions.

E.5 End points

E.5.1

Primary end point(s)

Persistence of antibodies in all subjects with respect to components of the investigational vaccine:
•rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY titres ≥1:8 at 32, 44, 56 and 68 months after primary vaccination

E.5.1.1

Timepoint(s) of evaluation of this end point

32, 44, 56, 68 and 69 months after the primary vaccination.

E.5.2

Secondary end point(s)

Immunogenicity at 32, 44, 56 and 68 months after primary vaccination in terms of
•rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥1:128 and GMTs
•hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY titres ≥1:4, ≥1:8 and GMTs in 50% of subjects.
Immunogenicity at one month post-booster with MenACWY-TT in terms of
•rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titres ≥1:8, ≥1:128, GMTs and rSBA vaccine response.
•hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibody titres ≥1:4, ≥1:8, GMTs and hSBA vaccine response.
Evaluate safety on Days 0-3 following the booster vaccination
•Occurrence of each solicited local and general symptom.
Evaluate safety on Days 0-30 following the booster vaccination
•Occurrence of unsolicited adverse events, SAEs and new onset of chronic illness.

E.5.2.1

Timepoint(s) of evaluation of this end point

32, 44, 56, 68 and 69 months after the primary 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

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

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

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

Menjugate® administered in study MENACWY-TT-081; EudraCT No: 2007-007837-38

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

Information not present in EudraCT

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

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.1.1.1

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.1.1.6

Adolescents (12-17 years)

Yes

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Subjects will be aged 7 through 16 years. Therefore, some subjects will be 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

200

F.4.2.2

In the whole clinical trial

200

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 the 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

2010-11-29

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2010-11-08

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-05-17

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