Clinical Trials Register

Summary
EudraCT Number:	2014-001713-26
Sponsor's Protocol Code Number:	CYD28
Clinical Trial Type:	Outside EU/EEA
Date on which this record was first entered in the EudraCT database:	2014-05-26
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
H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED

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A. Protocol Information

A.2

EudraCT number

2014-001713-26

A.3

Full title of the trial

Immunogenicity and Large-Scale Safety of Tetravalent Dengue Vaccine in Healthy Subjects Aged 2 to 45 Years in Singapore

A.3.1

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

Study of Sanofi Pasteur's Dengue Vaccine in Healthy Subjects Aged 2 to 45 Years in Singapore

A.4.1

Sponsor's protocol code number

CYD28

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT00880893

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/113/2014

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Sanofi Pasteur SA
B.1.3.4	Country	France
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 SA
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Sanofi Pasteur SA
B.5.2	Functional name of contact point	R&D, Clinical Development dpt
B.5.3	Address:
B.5.3.1	Street Address	1541 Avenue Marcel Mérieux
B.5.3.2	Town/ city	MARCY L'ETOILE
B.5.3.3	Post code	69280
B.5.3.4	Country	France
B.5.4	Telephone number	3304 37 65 60 60

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	CYD Dengue Vaccine
D.3.2	Product code	323
D.3.4	Pharmaceutical form	Powder and solvent for suspension for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Live, attenuated, chimeric dengue virus serotype 1
D.3.9.3	Other descriptive name	LIVE, ATTENUATED, CHIMERIC DENGUE VIRUS
D.3.9.4	EV Substance Code	SUB165738
D.3.10	Strength
D.3.10.1	Concentration unit	log10 CCID50/dose log10 cell culture infective dose 50/dose
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	4.5 to 6
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Live, attenuated, chimeric dengue virus serotype 2
D.3.9.3	Other descriptive name	LIVE, ATTENUATED, CHIMERIC DENGUE VIRUS
D.3.9.4	EV Substance Code	SUB165738
D.3.10	Strength
D.3.10.1	Concentration unit	log10 CCID50/dose log10 cell culture infective dose 50/dose
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	4.5 to 6
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Live, attenuated, chimeric dengue virus serotype 3
D.3.9.3	Other descriptive name	LIVE, ATTENUATED, CHIMERIC DENGUE VIRUS
D.3.9.4	EV Substance Code	SUB165738
D.3.10	Strength
D.3.10.1	Concentration unit	log10 CCID50/dose log10 cell culture infective dose 50/dose
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	4.5 to 6
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Live, attenuated, chimeric dengue virus serotype 4
D.3.9.3	Other descriptive name	LIVE, ATTENUATED, CHIMERIC DENGUE VIRUS
D.3.9.4	EV Substance Code	SUB165738
D.3.10	Strength
D.3.10.1	Concentration unit	log10 CCID50/dose log10 cell culture infective dose 50/dose
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	4.5 to 6
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	Yes
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection
D.8.4	Route of administration of the placebo	Subcutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Prevention of symptomatic dengue disease

E.1.1.1

Medical condition in easily understood language

Prevention of dengue disease with clinical symptoms

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

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

Safety and reactogenicity
Humoral immune response to dengue before and after each vaccination with CYD dengue vaccine

E.2.2

Secondary objectives of the trial

Persistence of the humoral immune response during 4 years after the last vaccination in a subset of subjects

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Aged from 2 to 45 years on the day of inclusion.
2. Subject in good health, based on medical h istory and physical examination.
3. Provision of informed consent form (and assent form for subjects aged 6 to 12 years) signed by the subject and by the parent(s) or another legally acceptable representative for subjects aged less than 21 years.
4. Subject and parent(s)/legally acceptable representative able to attend all scheduled visits and comply with all trial procedures.
5. For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks before the first vaccination until 4 weeks after the last vaccination.

E.4

Principal exclusion criteria

1. Febrile illness (temperature ≥37.5°C) or moderate or severe acute illness/infection on the day of the first vaccination, according to Investigator judgment.
2. For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test on the day of inclusion.
3. Breast-feeding woman.
4. Known systemic hypersensitivity to any of the components of the trial vaccines (especially egg proteins or neomycin) or h istory of a life-threatening reaction to the trial vaccines or to a vaccine containing any of the same substances.
5. Personal or family history of thymic pathology or myasthenia.
6. Previous hepatitis A vaccination (for children only).
7. Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the past 6 months, or long-term systemic corticosteroid therapy.
8. Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
9. Receipt of blood or blood-derived products in the past 3 months that might interfere with the assessment of immune response.
10. Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination.
11. Planned participation in another clinical trial during the 18 coming months.
12. Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
13. Planned receipt of any vaccine in the 4 weeks following the first trial vaccination.
14. Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
15. Current or past alcohol abuse or drug addiction that may interfere with the subject’s ability to comply with trial procedures.
16. Subject who plans to move to another country within the 18 coming months.

E.5 End points

E.5.1

Primary end point(s)

Safety and reactogenicity: adverse events, and serious adverse events
Humoral immune response: Dengue immune response (serotype specific neutralizing antibodies)

E.5.1.1

Timepoint(s) of evaluation of this end point

Safety and reactogenicity:
- Up to day 28 (D28) after each CYD dengue vaccine injection for AEs
- Throughout the trial for SAEs as follows: all SAEs up to 6 months after the third injection. Related and/or fatal SAEs from 6 months after the third injection until the end of the study
Humoral immune response: Prior to and 28 days (D28) after each injection

E.5.2

Secondary end point(s)

Persistence of antibodies: Dengue immune response (serotype specific neutralizing antibodies)

E.5.2.1

Timepoint(s) of evaluation of this end point

Each year during 4 years after the last 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

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

Yes

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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

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

Yes

E.8.1.7.1

Other trial design description

Observer-blind (first injection), single-blind (second and third injection)

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

At 0 Mo: Placebo (NaCl 0.9%); At 6 and 12 Mo: Havrix (if <12 years) or Vaxigrip (if = or > 12 years)

E.8.2.4

Number of treatment arms in the trial

E.8.3

Will this trial be conducted at a single site globally?

E.8.4

Will this trial be conducted at multiple sites globally?

Yes

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

Singapore

E.8.7

Trial has a data monitoring committee

Yes

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

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:

503

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:

316

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

187

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

695

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

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

1198

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

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

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