Clinical Trials Register

Summary
EudraCT Number:	2014-004492-23
Sponsor's Protocol Code Number:	V59P18
Clinical Trial Type:	Outside EU/EEA
Date on which this record was first entered in the EudraCT database:	2014-11-11
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
H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED

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A. Protocol Information

A.2

EudraCT number

2014-004492-23

A.3

Full title of the trial

A Phase 3, Single Center, Open-label, Controlled, Randomized Study to Evaluate the Safety and Immunogenicity of Novartis Men ACWY vaccine administered either alone or concomitantly with a Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine (Tdap, Boostrix®) and Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine (GARDASIL®) in Healthy Adolescents

A.3.1

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

A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In Adolescents

A.4.1

Sponsor's protocol code number

V59P18

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT00518180

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/93/2011

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Novartis Vaccines and Diagnostics Srl
B.1.3.4	Country	Italy
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	Novartis Vaccines and Diagnostics Srl
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Novartis Vaccines and Diagnostics Srl
B.5.2	Functional name of contact point	Posting Director
B.5.3	Address:
B.5.3.1	Street Address	Via Fiorentina, 1
B.5.3.2	Town/ city	Siena
B.5.3.3	Post code	53100
B.5.3.4	Country	Italy
B.5.6	E-mail	RegistryContactVaccinesUS@novartis.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	Novartis MenACWY vaccine
D.3.2	Product code	V59
D.3.4	Pharmaceutical form	Powder and 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.3.11 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	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	Boostrix
D.2.1.1.2	Name of the Marketing Authorisation holder	GlaxoSmithKline
D.2.1.2	Country which granted the Marketing Authorisation	United States
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	Tdap, Boostrix
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
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: 3
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.2.1.1.1	Trade name	Gardasil
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck & Co., Inc
D.2.1.2	Country which granted the Marketing Authorisation	United States
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	Quadrivalent Human Papillomavirus [Types 6, 11, 16,18] Recombinant Vaccine
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
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

Prophylaxis for Neisseria meningitidis serogroups A, C, W, and Y

E.1.1.1

Medical condition in easily understood language

Meningococcal disease

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

Immune responses to MenACWY, when given: (a) concomitantly with Tdap and HPV; and (b) when given one month after Tdap, were not inferior to the immune response when MenACWY was administered alone;
• Immune response to Tdap, when given concomitantly with MenACWY and HPV, was not inferior to immune response when Tdap was administered alone

E.2.2

Secondary objectives of the trial

a.To demonstrate that the immune response to HPV vaccine given concomitantly with MenACWY and Tdap is not inferior to the response when HPV is given alone.
b. To demonstrate that the immune response to Tdap administered alone one month after MenACWY is not inferior to the immune response to Tdap administered alone one month prior to MenACWY
c. To assess the immunogenicity of MenACWY as measured by hSBA geometric mean titers (GMTs) and by the percentage of subjects with hSBA≥1:4 and hSBA ≥ 1:8, directed against N. meningitidis serogroups A, C, W and Y.
d. To assess the immunogenicity of Tdap administered alone or concomitant with MenACWY and HPV as measured by anti-diphtheria and anti-tetanus GMCs and the percentage of subjects with a four-fold rise in antibody over baseline for anti-PT, anti- FHA, and anti-PRN titer
Safety: Describe and compare the safety profile of MenACWY in 3 study groups, and the safety profile of the HPV vaccine when given alone or with Tdap and MenACWY.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

a.Healthy adolescents 11-18 years of age
b.virgins (both male and female) with no intention of becoming sexually active during the study period
c.who have been properly vaccinated against diphtheria, tetanus, pertussis

E.4

Principal exclusion criteria

a.who had a previous confirmed or suspected disease caused by N. meningitidis;
b.who have previously been immunized with a meningococcal vaccine
c.who have received prior human papillomavirus (HPV) vaccine;
d.who have any serious acute, chronic or progressive disease
e.who have epilepsy, any progressive neurological disease or history of Guillain-Barre syndrome;
f.who have a known or suspected impairment/alteration of immune function, either congenital or acquired
g.who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
h.who have Down's syndrome or other known cytogenic disorders;

E.5 End points

E.5.1

Primary end point(s)

Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse
Percentage of Subjects With Antidiphtheria and Antitetanus Toxin ≥1.0 IU/mL
Geometric Mean Concentrations (GMC) of Antipertussis Toxin [Anti-PT], Antifilamentous Hemagglutinin [Anti-FHA], and Antipertactin [Anti-PRN]

E.5.1.1

Timepoint(s) of evaluation of this end point

1 month post MenACWY vaccination
1 month post Tdap vaccination

E.5.2

Secondary end point(s)

hSBA Geometric Mean Titers (GMTs) for A, C, W, and Y Serogroups
Percentage of Subjects With Anti-HPV Seroconversion
Geometric Mean Titers (GMTs) of Anti-HPV antibodies
Percentage of Subjects With hSBA ≥ 1:8 , hSBA titer < 1:4 and hSBA titer ≥ 1:4 for A, C, W, and Y Serogroups
Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus
Geometric Mean Titers (GMT) of Pertussis Antigens
Percentages of Subjects With at Least a 4-fold Rise for PT, FHA, and PRN
Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination
Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination

E.5.2.1

Timepoint(s) of evaluation of this end point

1 month post MenACWY vaccination
1 month after third HPV vaccination
1 month post Tdap vaccination
Days 1 to 7

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

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

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

Yes

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Boostrix and Gardasil

E.8.2.4

Number of treatment arms in the trial

E.8.3

Will this trial be conducted at a single site globally?

Yes

E.8.4

Will this trial be conducted at multiple sites globally?

E.8.6 Trial involving sites outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Yes

E.8.6.3

Specify the countries outside of the EEA in which trial sites are planned

Costa Rica

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

30 SEP 08-LSLV

E.8.9 Initial estimate of the duration of the trial

E.8.9.2

In all countries concerned by the trial years

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:

1620

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:

1620

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

Children <18 yrs old can't give consent personally.

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.2

For a multinational trial

F.4.2.2

In the whole clinical trial

1620

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)

Novartis Vaccines or the investigator provided the ethics committee (EC) with all appropriate material, including the Informed Consent Form (ICF), according to local regulations. The EC should also was asked for a written statement regarding the composition of the committee and to comply with GCP (Good Clinical Practices) and with the applicable regulatory requirement(s). The trial was not initiated until appropriate EC approval of the protocol and the ICF was obtained.

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	Instituto de Atencion Pediatrica
G.4.3.4	Network Country	Costa Rica

H.4 Third Country in which the Trial was first authorised
H.4.1	Third Country in which the trial was first authorised:	Costa Rica

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