Clinical Trials Register

Summary
EudraCT Number:	2014-001709-41
Sponsor's Protocol Code Number:	CYD22
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

2014-001709-41

A.3

Full title of the trial

Immunogenicity and Safety of Tetravalent Dengue Vaccine in Healthy Subjects Aged 2 to 45 Years in Viet Nam

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 Viet Nam

A.4.1

Sponsor's protocol code number

CYD22

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT00875524

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

Humoral immune response to dengue before and after each vaccination with CYD dengue vaccine
Persistence of antibodies (Abs) against dengue during 5 years after the first vaccination with CYD dengue vaccine
Safety and reactogenicity

E.2.2

Secondary objectives of the trial

Detection of symptomatic dengue cases occurring at any time in the study

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1) Aged 2 to 45 years on the day of inclusion. (Scr.)
2) Provision of Informed Consent/Assent Form signed by the subject (and/or by the parent or another legally acceptable representative for subjects <18 years). (Scr.)
3) Subject (and parent/guardian for subjects <18 years) able to attend all scheduled visits and to comply with all trial procedures. (Scr. + V01)
4) For a female subject of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to the first vaccination, until at least 4 weeks after the last vaccination. (Scr. + V01)
5) Subject in good health, based on medical history, physical examination and laboratory parameters. (Scr. + V01)

E.4

Principal exclusion criteria

1) Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia. (Scr.)
2) For a female subject of child-bearing potential, known pregnancy or positive serum pregnancy test at Screening. (Scr.)
3) For a female subject of child-bearing potential, known pregnancy or positive urine pregnancy test on the day of the first injection. (V01)
4) Breast-feeding female subject. (Scr.)
5) Receipt of any vaccine in the 4 weeks preceding the first trial vaccination. (Scr.)
6) Human immunodeficiency virus, hepatitis B, or hepatitis C seropositivity in the blood sample taken at screening. (V01)
7) Planned participation in another clinical trial during the first year of the study. (Scr.)
8) 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 corticosteroids therapy. (Scr.)
9) Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccines or to a vaccine containing any of the same substances. (Scr.)
10) Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator. (Scr.)
11) Current alcohol abuse or drug addiction that may interfere with the subject’s ability to comply with trial procedures. (Scr.)
12) Receipt of blood or blood-derived products in the past 3 months that might interfere with the assessment of immune response. (Scr.)
13) Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent. (Scr.)
14) Laboratory abnormalities of at least moderate severity or clinically significant according to the Investigator in blood sample taken at screening. (V01)
15) Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination. (Scr. + V01)
16) Planned receipt of any vaccine in the 4 weeks following the first trial vaccination. (V01)
17) Familial atopy medical history (parents, brothers, or sisters). (Scr.)
18) Previous vaccination with meningococcal A + C or typhoid vaccines within 3 years prior to inclusion. (Scr.)
The exclusion criterion #18 was modified at the time of Amendment 1 (protocol Version 3.0 dated 08 April 2008) for accuracy.
19) History of meningococcal or typhoid infections (confirmed either clinically, serologically or microbiologically). (Scr.)

E.5 End points

E.5.1

Primary end point(s)

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

E.5.1.1

Timepoint(s) of evaluation of this end point

Humoral immune response: Prior to and 28 days (D28) after each injection
Persistence of antibodies each year during 5 years after the first injection

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

E.5.2

Secondary end point(s)

Detection of symptomatic dengue cases

E.5.2.1

Timepoint(s) of evaluation of this end point

Any time in the study

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

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: Meningococcal Polysaccharide Vaccine A+C; At 6 Mo: Placebo; At 12 Mo: Typhim Vi

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

Vietnam

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:

150

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:

120

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

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

180

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:	Vietnam

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