Clinical Trials Register

Summary
EudraCT Number:	2013-001549-15
Sponsor's Protocol Code Number:	C0921004
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:	2013-08-26
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

2013-001549-15

A.3

Full title of the trial

The long-term antibody persistence of MenACWY-TT vaccine (PF-06866681) versus Meningitec® or Mencevax® ACWY in healthy adolescents and adults and a booster dose of MenACWY-TT administered 10 years post-primary vaccination.

Vasta-aineiden pitkäaikainen pysyvyys terveillä nuorilla ja aikuisilla MenACWY-TT-rokotteen (PF-06866681) antamisen jälkeen verrattuna Meningitec® tai Mencevax® ACWY rokotteeseen sekä MenACWY-TT-rokotteen tehosteannoksen aikaansaama vaste 10 vuotta ensimmäisen rokotuksen jälkeen annettuna.

A.3.1

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

To evaluate the safety and immunogenicity of a booster dose of meningococcal vaccine administered 10 years after primary vaccination of 1-10 year old subjects with MenACWY-TT (PF-06866681), Meningitec or Mencevax ACWY.

A.3.2

Name or abbreviated title of the trial where available

C0921004 (MenACWY-TT-100 EXT:027 Y6,7,8,9,10)

A.4.1

Sponsor's protocol code number

C0921004

A.5.4

Other Identifiers

Name:

KL nro

Number:

104/2013

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	Pfizer Inc (235 East 42nd Street, New York, New York 10017)
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	Pfizer Inc (235 East 42nd Street, New York, New York 10017)
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	Pfizer Inc
B.5.2	Functional name of contact point	Clinical Trials.gov Call Centre
B.5.3	Address:
B.5.3.1	Street Address	235 E 42nd Street,
B.5.3.2	Town/ city	New York
B.5.3.3	Post code	NY 10017
B.5.3.4	Country	United States
B.5.4	Telephone number	+18007181021
B.5.5	Fax number	+13037391119
B.5.6	E-mail	ClinicalTrials.govCallCentre@pfizer.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.3.2	Product code	MenACWY-TT
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

Meningococcal disease

E.1.1.1

Medical condition in easily understood language

Healthy adolescent and adult volunteers (Active immunization against invasive disease caused by Neisseria meningitidis serogroups A, C, W-135 and Y 10 years after primary vaccination.)

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	18.1
E.1.2	Level	LLT
E.1.2	Classification code	10028910
E.1.2	Term	Neisseria meningitides meningitis
E.1.2	System Organ Class	100000004862

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.1
E.1.2	Level	LLT
E.1.2	Classification code	10028912
E.1.2	Term	Neisseria meningitis sepsis
E.1.2	System Organ Class	100000004862

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.1
E.1.2	Level	LLT
E.1.2	Classification code	10027276
E.1.2	Term	Meningococcal meningitis
E.1.2	System Organ Class	100000004862

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.1
E.1.2	Level	LLT
E.1.2	Classification code	10058885
E.1.2	Term	Meningococcal bacteremia
E.1.2	System Organ Class	100000004862

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.1
E.1.2	Level	LLT
E.1.2	Classification code	10027275
E.1.2	Term	Meningococcal infection, unspecified
E.1.2	System Organ Class	100000004862

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.1
E.1.2	Level	LLT
E.1.2	Classification code	10040048
E.1.2	Term	Sepsis meningococcal
E.1.2	System Organ Class	100000004862

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 evaluate the long-term persistence of the serum bactericidal (antibody) titres induced by MenACWY-TT vaccine as compared to Meningitec when administered to individuals 1-<2 years of age in terms of the percentage of subjects with Neisseria meningitidis serogroup A (MenA), serogroup C (MenC), serogroup W-135 (MenW-135), and serogroup Y (MenY) titres ≥1:8, ≥1:128 and GMTs as measured by a serum bactericidal assay using rabbit complement (rSBA) in those subjects that received MenACWY-TT, and serogroup C (MenC) rSBA titres ≥1:8, ≥1:128 and GMTs in those subjects that received Meningitec.
Mencevax ACWY when administered to individuals 2-10 years of age in terms of the percentage of subjects with Neisseria meningitidis MenA, MenC, MenW-135, and MenY titres ≥1:8, ≥1:128 and GMTs as measured by a serum bactericidal assay using rSBA.

E.2.2

Secondary objectives of the trial

•Evaluation of the long-term persistence induced by MenACWY-TT vaccine in terms of percentage of subjects with hSBA titres ≥1:4, ≥1:8 and GMTs as compared to Meningitec when administered to individuals 1-<2 years of age.
-Mencevax ACWY when administered to individuals 2-10 years of age.
•To describe SAEs related to vaccination and any event related to lack of vaccine efficacy from the last persistence time point the subject participated in up to each yearly visit in the current study in a retrospective manner.
•Evaluate the immunogenicity of a booster dose vaccination of MenACWY-TT with respect to the percentage of subjects with rSBA-MenA, MenC, MenW-135, and MenY antibody (Ab) titres ≥1:8, ≥1:128 and GMTs.
-hSBA-MenA, MenC,MenW-135, and MenY Ab titres ≥1:4, ≥1:8 and GMTs.
-an rSBA-MenA, MenC,MenW-135, MenY and MenA, MenC, MenW-135, MenY booster response.
•Evaluate safety and reactogenicity of a booster vaccination dose of MenACWY-TT vaccine.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

•Subjects and/or subjects’ parent(s)/Legally Acceptable Representative(s) (LARs) who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
•A male or female who has received a primary vaccination with the MenACWY-TT, Meningitec or Mencevax ACWY vaccines in study MenACWY-TT-027 (108658).
•In alignment with local laws and regulations, written informed consent obtained from parents/LAR(s) of the subject and written informed assent obtained from the subject if the subject is less than 15 years of age, or written informed consent obtained from the subject if the subject has achieved the 15th birthday. The subjects ≥15 years of age at the time of enrolment will sign the informed consent form, even if the parent/ LAR previously signed the ICF before the subject reached the legal age of consent.
•Healthy subjects as established by medical history and history-directed physical examination before entering into the study.
All subjects must satisfy the following additional criteria prior to entry of the booster phase:
•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 (for Female only), and
-has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

E.4

Principal exclusion criteria

•Child in care
•Previus vaccination with meningococcal polysaccharide or conjugate vaccine outside of study MenACWY-TT-027.
Note: Subjects who were revaccinated with a monovalent MenC conjugate vaccine because of suboptimal response during the persistence phase of the MenACWY-TT-027 study (i.e. MenACWY-TT-028, -029, -030, -031 and -032) are allowed to participate as they will be followed for the persistence of MenA, MenW-135 and MenY.
•History of meningococcal disease due to serogroup A, C, W-135 or Y.
•Previous vaccination with meningococcal B vaccine.
•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 required).
•Family history of congenital or hereditary immunodeficiency.
•Major congenital defects or serious chronic illness.
•History of chronic alcohol consumption and/or drug abuse.
•Subjects who withdrew consent to be contacted for follow-up studies
Additional exclusion criteria for booster phase at Month 126 study entry (to be checked at Month 126) for all subjects
•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the follow-up period.
•Administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the booster dose of study vaccine or planned administration within 30 days after vaccination, with the exception of a licensed inactivated influenza vaccine.
•Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose (for corticosteroids, this will mean prednisone ≥ 10 mg/day, or equivalent). Inhaled and topical steroids are allowed.
•Administration of immunoglobulins and/or any blood products within the three months preceding the booster vaccination or planned administration during the follow-up period.
•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).
•History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
•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, tympanic, or ≥38.0°C for rectal route. The preferred route for recording temperature in this study will be oral.
-Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
•Pregnant or lactating female.
•Female planning to become pregnant or planning to discontinue contraceptive precautions.
• Male subjects able to father children who are planning to discontinue contraceptive precautions.
• Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees directly involved in the conduct of the study.

E.5 End points

E.5.1

Primary end point(s)

rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titres ≥1:8, ≥1:128 and GMTs.

E.5.1.1

Timepoint(s) of evaluation of this end point

Six, seven, eight, nine and ten years after primary vaccination in study MenACWY-TT-027.

E.5.2

Secondary end point(s)

•hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibody titres ≥1:4, ≥1:8 and GMTs
•rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titres ≥1:8, ≥1:128 and GMTs and rSBA booster response.
•hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibody titres ≥1:4, ≥1:8 and GMTs and hSBA booster response.
Occurrence of serious adverse events related to vaccination and any event related to lack of vaccine efficacy (i.e. meningococcal disease) since the last persistent time point the subject participated in up to each yearly visit in the current study in a retrospective manner.
Occurrence of solicited local and general symptoms on following the booster vaccination.
Occurrence of unsolicited adverse events after vaccination with MenACWY-TT according to the Medical Dictionary for Regulatory Activities (MedDRA).
Occurrence of all serious adverse events after vaccination with MenACWY-TT.
New onset chronic illness(es) (e.g. autoimmune disorders, asthma, type 1 diabetes and allergies).

E.5.2.1

Timepoint(s) of evaluation of this end point

Six, seven, eight, nine and ten years after primary vaccination in study MenACWY-TT-027.
Prior to and one month post- booster vaccination.
Prior to and one month post-booster vaccination.
Since the last persistence time point the subject participated in up to each yearly visit in the current study in a retrospective manner.
Days 0-3 following vaccination with MenACWY-TT.
Days 0-30 following vaccination with MenACWY-TT.
From booster vaccination with MenACWY-TT up to six months after the booster vaccination.
From booster vaccination with MenACWY-TT up to six months after the booster 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

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

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

LSLV

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