Clinical Trials Register

Summary
EudraCT Number:	2007-002480-27
Sponsor's Protocol Code Number:	V87P6
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:	2007-06-20
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

2007-002480-27

A.3

Full title of the trial

A Phase II, Randomized, Controlled, Observer-blind, Single-center Study to Evaluate the Immunogenicity, Safety and Tolerability of Two Doses of FLUAD-H5N1 Influenza Vaccine in Subjects aged 6 months to 17 years

A.4.1

Sponsor's protocol code number

V87P6

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Novartis Vaccines and Diagnostics GmbH & Co. KG
B.1.3.4	Country	Germany
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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	FLUAD-H5N1
D.3.4	Pharmaceutical form	Suspension for injection
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	Influenza virus surface antigen (HA and NA), H5N1 (A/Vietnam/1194/2004 NIBRG-14)
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	7.5
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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	Comparator
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	FLUAD
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Vaccines and Diagnostics S.r.l. (formerly Chiron S.r.l.) - Via Fiorentina 1; Siena, Italy
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.3.4	Pharmaceutical form	Suspension for injection
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	Influenza A/Solomon Islands/3/2006 - like (H1N1) virus/15µg/0.5ml dose
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	15
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	Influenza A/Wisconsin/67/2005 - like (H3N2) virus/15µg HA/0.5mL dose
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	15
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	Influenza B/Malaysia/2506/2004 - like virus/15µg/0.5mL dose
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	15
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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

avian influenza

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	LLT
E.1.2	Classification code	10064097
E.1.2	Term	Avian influenza

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the safety and tolerability of and the magnitude of antibody responses to two 0.5mL intramuscular (IM) injections of FLUAD-H5N1 influenza vaccine each containing 7.5µg of A/H5N1 influenza antigen, administered 3 weeks apart.

E.2.2

Secondary objectives of the trial

To evaluate the safety and tolerability of one 0.5mL IM injection of FLUAD-H5N1 influenza vaccine containing 7.5µg of A/H5N1 influenza antigen, administered 12 months after the second dose.
To evaluate the magnitude of antibody response to a 12 months booster dose of FLUAD-H5N1 influenza vaccine, containing 7.5µg of H5N1 antigen in subjects of different ages.
To evaluate the persistence of specific antibodies 12 months after primary immunization in subjects of different ages.
To evaluate the cross-protection of a FLUAD-H5N1 influenza vaccine, containing 7.5µg of H5N1 antigen in subjects of different ages.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Female or male subjects aged 6 months to <18 years whose parents/legal guardians have signed an informed consent form after having received a detailed explanation of the study protocol. Subjects from 9 to <18 years of age additionally have to sign an assent form having received a detailed explanation of the study protocol.
2. Good health as determined by:
a. Medical history,
b. Physical examination,
c. Clinical judgment of the Investigator;
3. Able to comply with all study procedures, can be contacted, and will be available for all study visits

E.4

Principal exclusion criteria

1. Participation in another clinical study at the same time or within the last 3 months and unwilling to refuse participation in another clinical study through the end of this study;
2. Previous vaccination with a pandemic candidate vaccine and/or vaccine containing the adjuvant MF59 or a similar adjuvant;
3. Receipt of influenza vaccination for the current season 2007/2008;
4. Receipt of another vaccine within 3 weeks before and after each study vaccination;
5. Any acute disease or infection requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) within the past 7 days;
6. Fever (defined as axillary temperature ≥38.0°C) within 3 days prior to Visit 1,
7. Pregnant or breastfeeding;
8. Females of childbearing potential (i.e., after first menstrual bleeding until 2 years after last menstrual bleeding, except females with hysterectomy or abstinent females) who refuse to use an acceptable method of birth control for the duration of the study and who refuse to perform a urine pregnancy test prior to vaccination. Adequate contraception is defined as hormonal (e.g., oral, injection, transdermal patch, implant, cervical ring), barrier (e.g., condom with spermicide or diaphragm with spermicide), intrauterine device (e.g., IUD), or monogamous relationship with a vasectomized partner who has been vasectomized for 6 months or more prior to the subject’s study entry;
9. Any serious disease, such as:
a. Cancer,
b. Autoimmune disease (including rheumatoid arthritis),
c. Diabetes mellitus,
d. Asthma, chronic pulmonary disease (steroids administered by inhalation only or clinical symptoms less frequent than once a day are acceptable),
e. Acute or progressive hepatic disease,
f. Acute or progressive renal disease;
10. Known or suspected impairment/alteration of immune function, for example, resulting from:
a. Receipt of immunosuppressive therapy (corticosteroid -except topical or inhaled steroids- or cancer chemotherapy, immunoglobulins), asthma under inhalation therapy only acceptable,
b. Receipt of immunostimulants,
c. Receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months and for the full length of the study,
d. High risk for developing an immunocompromising disease;
11. Surgery planned during the study period;
12. Bleeding diathesis;
13. Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the study vaccine;
14. History of any neurological symptoms or signs, or anaphylactic shock following administration of any vaccine;
15. History of neurological disorder or seizures (febrile seizures allowed);
16. Children who are in the local recommendation for influenza vaccination;
17. History of (or current) drug or alcohol abuse that in the investigator’s opinion would interfere with safety of the subject or the evaluation of study objectives;
18. Any condition, which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.

E.5 End points

E.5.1

Primary end point(s)

The measures of immunogenicity, collected for all evaluable subjects of the FLUAD-H5N1 group include:
- Geometric mean titers/area (GMTs/GMAs) and geometric mean ratios (GMRs) on days 1, 22, and 43, 382 and day 403 as determined by HI, SRH, and MN.
- Percentage of subjects achieving seroconversion or significant increase in antibody titer on days 22, 43, 382, and 403 as measured by HI and SRH.
- Percentage of subjects with MN titers ≥1:20, ≥1:40, ≥1:80 on day 1, day 22, and day 43.
- Percentage of subjects achieving at least a four-fold rise in antibody titer on days 22, 43, 382, and 403 as measured by MN.
- Percentage of subjects achieving a titer ≥40/ area ≥25mm2 on days 22, 43, 382 and 403 as determined by HI and SRH.

Number and percentage of subjects with at least one local reaction between day 1 and day 7 after each vaccine injection.
Number and percentage of subjects with at least one systemic reaction between day 1 and day 7 days after each vaccine injection.
Number and percentage of subjects with at least one adverse event between day 1 and day 43 or between day 382 and day 403 (FLUAD-H5N1 group only).
Number and percentage of subjects with serious adverse events or adverse events necessitating a physician’s visit or consultation and/or leading to withdrawal from the study between day 1 and the study termination visit.

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

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)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the 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

Information not present in EudraCT

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

last subject last visit, here by phone call

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

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

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)

Yes

F.1.1.5

Children (2-11years)

Yes

F.1.1.6

Adolescents (12-17 years)

Yes

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

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

subjects younger than 18 years; subjects from 9 to <18 years of age additionally have to sign an assent form after having received a detailed explanation of the study protocol

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

469

G. Investigator Networks to be involved in the Trial

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2007-08-15

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2007-08-13

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2009-05-18

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