Clinical Trials Register

Summary
EudraCT Number:	2008-003824-51
Sponsor's Protocol Code Number:	112036
National Competent Authority:	Finland - Fimea
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2009-06-15
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

Finland - Fimea

A.2

EudraCT number

2008-003824-51

A.3

Full title of the trial

A phase III, open, multi-centre, controlled study to evaluate the long-term antibody persistence at 2 years, 3 years and 4 years after a single dose of GlaxoSmithKline (GSK) Biologicals’ meningococcal serogroup A, C, W-135, Y- tetanus toxoid conjugate (MenACWY-TT) vaccine versus one dose of Meningitec™ administered in healthy 12 through 23-month old children who were primed in study MenACWY-TT-039 (109670) and to evaluate the immunogenicity and safety of a booster dose of the same meningococcal conjugate vaccine as given in the primary study, 4 years after priming.

A.3.2

Name or abbreviated title of the trial where available

MENACWY-TT-048 EXT:039 Y2, 3, 4, 5

A.4.1

Sponsor's protocol code number

112036

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	MenACWY conjugate vaccine
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	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	N. meningitides serogroup A polysaccharide (PSA) conjugated to tetanus toxoid (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	PSA: 5 - TT: 15
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N. meningitides serogroup C polysaccharide (PSC) conjugated to tetanus toxoid (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	PSC: 5 - TT: 15
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N. meningitides serogroup W polysaccharide (PSW) conjugated to tetanus toxoid (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	PSW: 5 - TT: 7.5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N. Meningitides serogroup Y polysaccharide (PSY) conjugated to tetanus toxoid (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	PSY:5 - TT:6.5
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.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	Meningitec
D.2.1.1.2	Name of the Marketing Authorisation holder	Wyeth-Lederle Nordiska AB
D.2.1.2	Country which granted the Marketing Authorisation	Finland
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	Meningitec
D.3.2	Product code	Meningococcal group C oligosaccharide conjugate
D.3.4	Pharmaceutical form	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	N. meningitides serogroup C polysaccharide (PSC) conjugated to Corynebacterium diphteriae protein (CRM-197)
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	PSC:10 CRM197:15
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

Healthy male and female children who completed the primary immunisation study MenACWY-TT-039 (109670) and were 12 to 23 months of age at the time of primary vaccination.

MedDRA Classification

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 24, 36, and 48 months after primary vaccination of toddlers with MenACWY-TT or Meningitec
•To evaluate the persistence of meningococcal antibodies in terms of the percentage of subjects with rSBA antibody titres ≥ 1:8 for each of the four serogroups.

E.2.2

Secondary objectives of the trial

Immunogenicity
One month after the booster dose:
•To evaluate the immunogenicity of MenACWY-TT compared with Meningitec in terms of rSBA titre ≥1:128, rSBA, hSBA and anti-PS antibodies for serogroupC.
•To evaluate the fold increase in rSBA GMTs from pre (at Month 48) to post-booster time-point (at Month 49) for A, W-135 and Y serogroups.
•To evaluate the immunogenicity of MenACWY-TT in terms of rSBA, hSBA and anti-PS antibodies for A, W-135 and Y serogroups.
Persistence
•To evaluate the persistence of meningococcal A, C, W-135 and Y antibodies in terms of rSBA, hSBA and anti-PS antibodies for the four serogroups at 24, 36, 48 months after primary vaccination with a meningococcal conjugate vaccine and 12 months after booster vaccination.
Safety
•To evaluate the safety and reactogenicity of MenACWY-TT and Meningitec one month after the booster vaccine dose.
•To describe unsolicited symptoms and serious adverse events during the 31-day period (Days 0-30) following vaccination.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

•Subjects who the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
•Written informed consent obtained from the parent(s) or guardian(s) of the subject.
•Healthy subjects as established by medical history and clinical examination before entering into the study.
•A male or female having completed the primary study MenACWY-TT-039 (109670) and who was primed with MenACWY-TT or Meningitec vaccines.

E.4

Principal exclusion criteria

Exclusion criteria for persistence study entry (i.e. Month 24, 36 or 48):
•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the subject’s first visit.
•History of meningococcal disease*.
•Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine outside of study MenACWY-TT-039 (109670).
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history (no laboratory testing is required).
•Administration of immunoglobulins and/or blood products within the three months preceding the subjects first visit.
•Concurrently participating in another clinical study, within 30 days of study entry, 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.
* Meningococcal disease history has to be documented using a SAE form.
Additional exclusion criteria for booster vaccination (to be checked at Month 48):
•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).
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
•Hypersensitivity to any vaccine containing diphtheria toxoid or non-toxic diphtheria toxin protein and/or tetanus toxoid.
•History of hypersensitivity after previous administration of Meningitec or MenACWY-TT in study MenACWY-TT-039 (109670).
•Hypersensitivity to latex.
•Planned administration/ administration of a vaccine not foreseen by the protocol within one month before and 30 days after the booster dose.
•Previous vaccination with tetanus and diphtheria toxoids within the last month (i.e., Tdap, Td and TT-containing vaccine within the last month).
•History of any neurological disorder or seizures (one episode of febrile convulsion does not constitute an exclusion criteria).
•Major congenital defects or serious chronic illness.
•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 diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature < 37.5°C (99.5°F) / Axillary temperature < 37.5°C (99.5°F) / Rectal temperature < 38°C (100.4°F) / Tympanic temperature on oral setting < 37.5°C (99.5°F).

E.5 End points

E.5.1

Primary end point(s)

Persistence of immunogenicity with respect to components of the investigational vaccine, 24, 36, 48 months post primary dose:
•rSBA-MenA titres ≥ 1:8.
•rSBA-MenC titres ≥ 1:8.
•rSBA-MenW-135 titres ≥ 1:8.
•rSBA-MenY titres ≥ 1:8.

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

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

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

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)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

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

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)

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

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 incapable of giving consent personally since they are aged 12 through 23 months at the time of primary vaccination (MenACWY-TT-039, 109670)

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

992

F.4.2

For a multinational trial

F.4.2.1

In the EEA

992

F.4.2.2

In the whole clinical trial

992

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)

-Subjects with a response below the predefined cut-off of 1:8 to N. meningitidis serogroup C one month after the booster vaccination will be offered an extra dose of a licensed vaccine.
-Subjects who received an extra dose of a licensed meningococcal vaccine will not enter the long-term follow-up of the year that follows and the reason will be documented.

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

2009-08-14

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2009-08-11

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2012-09-10

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