Clinical Trials Register

Summary
EudraCT Number:	2017-001993-40
Sponsor's Protocol Code Number:	MET62
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:	2017-10-18
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

2017-001993-40

A.3

Full title of the trial

Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered as a Booster Dose in Children Vaccinated 3 Years Earlier as Toddlers

A.3.1

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

Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered as a Booster Dose in Children Vaccinated 3 Years Earlier as Toddlers

A.4.1

Sponsor's protocol code number

MET62

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1183-5988

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	Sanofi Pasteur
B.1.3.4	Country	United States
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	Sanofi Pasteur
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Sanofi Pasteur
B.5.2	Functional name of contact point	Clinical Team Leader
B.5.3	Address:
B.5.3.1	Street Address	1541, avenue Marcel Merieux
B.5.3.2	Town/ city	Marcy l'Etoile
B.5.3.3	Post code	69280
B.5.3.4	Country	France
B.5.6	E-mail	diane.vandervliet@sanofipasteur.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.3.1	Product name	MenACYW Conjugate Vaccine
D.3.2	Product code	395
D.3.4	Pharmaceutical form	Solution 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.3.9.3	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	10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	NEISSERIA MENINGITIDIS SEROGROUP C POLYSACCHARIDE (PSC) CONJUGATED TO TETANUS TOXOID (TT)
D.3.9.3	Other descriptive name	NEISSERIA MENINGITIDIS SEROGROUP C POLYSACCHARIDE (PSC) CONJUGATED TO TETANUS TOXOID (TT)
D.3.9.4	EV Substance Code	SUB31471
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	10
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.3.9.3	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	10
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.3.9.3	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	10
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)	No
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 meningococcal vaccine primed male and female children aged 4-5 years who were previously vaccinated 3 years (± 45 days) earlier at 12 to 23 months of age in study MET54

E.1.1.1

Medical condition in easily understood language

Healthy meningococcal vaccine primed male and female children aged 4-5 years who were previously vaccinated 3 years (± 45 days) earlier at 12 to 23 months of age in study MET54

E.1.1.2

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

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
1) To describe the antibody persistence of meningococcal serogroups A,
C, Y, and W before a booster dose in children who received either
MenACYW conjugate vaccine or Nimenrix® 3 years earlier as toddlers

2) To describe the antibody responses to meningococcal serogroups A, C,
Y, and W 30 days after a booster dose of MenACYW conjugate
vaccine in children who received either

3) To describe the antibody responses against tetanus toxoid 30 days after
a booster dose of MenACYW conjugate vaccine in children who
received either MenACYW conjugate vaccine or Nimenrix® 3 years
earlier as toddlers

Safety
To describe the safety profile of a booster dose of MenACYW conjugate
vaccine in children who received either MenACYW conjugate vaccine or
Nimenrix® 3 years earlier as toddlers

E.2.2

Secondary objectives of the trial

Not Applicable

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

An individual must fulfill all of the following criteria in order to be eligible
for trial enrollment:
1) Participated in and completed (attended Visit 2) study MET54

2) Informed consent form has been signed and dated by the parent(s) or
another legally acceptable representative (and by an independent
witness, if required by local regulations)

3) Subject and parent/legally acceptable representative are able to attend
all scheduled visits and to comply with all trial procedures

E.4

Principal exclusion criteria

An individual fulfilling any of the following criteria is to be excluded from
trial enrollment:
1) Participation in the 4 weeks preceding the trial vaccination or planned
participation during the present trial period in another clinical trial
investigating a vaccine, drug, medical device, or medical procedure

2) Receipt of any vaccine in the 4 weeks (28 days) preceding the trial
vaccination or planned receipt of any vaccine prior to Visit 2 except for
influenza vaccination, which may be received at a gap of at least
2 weeks before or after the study vaccines. This exception includes
monovalent pandemic influenza vaccines and multivalent influenza
vaccines. If the subject is due to receive vaccination(s) recommended
for his / her age by the national immunization schedule at the time of
the study, the subject will be recommended to complete his/her
immunization schedule after Visit 2.

3) Previous vaccination against meningococcal disease with either the trial
vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or
conjugate meningococcal vaccine containing serogroups A, C, Y, or W;
or meningococcal B vaccine) with the exception of the single dose of
meningococcal vaccine administered as part of study MET54

4) Receipt of immune globulins, blood or blood-derived products in the
past 3 months

5) Known or suspected congenital or acquired immunodeficiency; or
receipt of immunosuppressive therapy, such as anti-cancer
chemotherapy or radiation therapy, within the preceding 6 months; or
long-term systemic corticosteroid therapy (prednisone or equivalent for
more than 2 consecutive weeks within the past 3 months)

6) History of meningococcal infection, confirmed either clinically,
serologically, or microbiologically

7) At high risk for meningococcal infection during the trial (specifically,
but not limited to, subjects with persistent complement deficiency, with
anatomic or functional asplenia, or subjects traveling to countries with
high endemic or epidemic disease)

8) Known systemic hypersensitivity to any of the vaccine components, or
history of a life-threatening reaction to the vaccine used in the trial or to
a vaccine containing any of the same substances

9) Verbal report of thrombocytopenia, contraindicating intramuscular
vaccination in the Investigator’s opinion

10) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding
inclusion, contraindicating intramuscular vaccination

11) Personal history of Guillain-Barré syndrome (GBS)

12) Personal history of an Arthus-like reaction after vaccination with a
tetanus toxoid-containing vaccine

13) Chronic illness that, in the opinion of the Investigator, is at a stage
where it might interfere with trial conduct or completion

14) Moderate or severe acute illness/infection (according to Investigator
judgment) on the day of vaccination or febrile illness (temperature
≥ 38.0°C). A prospective subject should not be included in the study
until the condition has resolved or the febrile event has subsided

15) Receipt of oral or injectable antibiotic therapy within 72 hours prior to
the first blood draw.

16) Identified as a natural or adopted child of the Investigator or employee
with direct involvement in the proposed study

E.5 End points

E.5.1

Primary end point(s)

Immunogenicity
1) Antibody titers against meningococcal serogroups A, C, Y, and W
measured by hSBA and rSBA :
a) At D0 (baseline) and D30 in toddlers after having received a single
dose of either MenACYW conjugate vaccine or Nimenrix®, as part
of study MET54
b) At D0 (baseline) in children before receiving a booster dose of
MenACYW conjugate vaccine as part of study MET62 (3 years after
having received a single dose of either MenACYW conjugate
vaccine or Nimenrix®)

2) Antibody titers against meningococcal serogroups A, C, Y, and W
measured by rSBA and hSBA at D0 (baseline) and D30 after the
administration of a booster dose of MenACYW conjugate vaccine in
children who received either MenACYW conjugate vaccine or
Nimenrix® 3 years earlier as toddlers

Tetanus toxoid is contained as a carrier protein in both the investigational vaccine and the control vaccine that was used in study MET54. Therefore, blood samples will also be tested to assess:

3) Antibody concentrations against tetanus toxoid at D0 (baseline) and
D30 after the administration of a booster dose of MenACYW
conjugate vaccine in children who received either MenACYW
conjugate vaccine or Nimenrix® 3 years earlier as toddlers

Safety
• Occurrence, nature (Medical Dictionary for Regulatory Activities
[MedDRA] preferred term [PT]), duration, intensity, and relationship to
vaccination of any unsolicited systemic AEs reported in the 30 minutes
after vaccination
• Occurrence, time of onset, number of days of occurrence, intensity,
action taken, and whether the reaction led to early termination from the
study, of solicited (prelisted in the subject’s diary card and electronic
case report form [CRF]) injection site reactions occurring up to 7 days
after vaccination
• Occurrence, time of onset, number of days of occurrence, intensity,
action taken, and whether the reaction led to early termination from the
study, of solicited (prelisted in the subject’s diary card and CRF)
systemic reactions occurring up to 7 days after vaccination
• Occurrence, nature (MedDRA PT), time of onset, duration, intensity,
action taken, relationship to vaccination (for systemic AEs only), and
whether the event led to early termination from the study, of unsolicited
AEs up to Visit 2 after vaccination
• Occurrence, nature (MedDRA PT), time of onset, duration, seriousness
criteria, relationship to vaccination, outcome, and whether the SAE led
to early termination from the study, of SAEs, including AESIs,
throughout the trial

E.5.1.1

Timepoint(s) of evaluation of this end point

The duration of each subject's participation in the study will be 30 to 44 days which includes one day for vaccination, 30 days of safety follow up, and a postvaccination
sample at Visit 2 (30 to 44 days after the vaccination at Visit 1).

E.5.2

Secondary end point(s)

Not Applicable

E.5.2.1

Timepoint(s) of evaluation of this end point

Not Applicable

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

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

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

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

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 in October 2018

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

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:

188

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:

188

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.4.1

In the member state

188

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
G.4 Investigator Network to be involved in the Trial: 1

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2017-12-08

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-10-24

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-09-10

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