Clinical Trials Register

Summary
EudraCT Number:	2014-001836-12
Sponsor's Protocol Code Number:	ITMC0414
National Competent Authority:	Belgium - FPS Health-DGM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2014-06-24
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

Belgium - FPS Health-DGM

A.2

EudraCT number

2014-001836-12

A.3

Full title of the trial

Boostability for rabies in last-minute travelers: One Day Rabies Pre-exposure Intradermal Vaccination followed by one day Postexposure Intradermal Vaccination

A.3.1

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

Simplifying the rabies vaccination

A.3.2

Name or abbreviated title of the trial where available

Simplifying the rabies vaccination

A.4.1

Sponsor's protocol code number

ITMC0414

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	Institute of Tropical Medicine
B.1.3.4	Country	Belgium
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Military Hospital Queen Astrid, Brussels
B.4.2	Country	Belgium
B.4.1	Name of organisation providing support	Institute of Tropical Medicine
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Institute of Tropical Medicine
B.5.2	Functional name of contact point	Clinical Trials Unit
B.5.3	Address:
B.5.3.1	Street Address	Nationalestraat 155
B.5.3.2	Town/ city	Antwerp
B.5.3.3	Post code	2000
B.5.3.4	Country	Belgium
B.5.4	Telephone number	003232476625
B.5.5	Fax number	003232476647
B.5.6	E-mail	rravinetto@itg.be

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	Rabipur
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis AG
D.2.1.2	Country which granted the Marketing Authorisation	Belgium
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	Rabipur
D.3.4	Pharmaceutical form	Lyophilisate for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intradermal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	/
D.3.9.1	CAS number	/
D.3.9.2	Current sponsor code	/
D.3.9.3	Other descriptive name	RABIES VIRUS (INACTIVATED) STRAIN FLURY LEP
D.3.9.4	EV Substance Code	SUB25746
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	2.5
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

Rabies is a viral infection that affects the central nervous system. It
causes encephalitis which is almost invariably fatal. Preventive
vaccination alone implies no complete protection, but simplifies the post-exposure procedure considerably, as the immunological response comes
much more rapid in case of a booster vaccination post-exposure. This
lowers the risk of morbidity and mortality.

E.1.1.1

Medical condition in easily understood language

Vaccination to prevent rabies infection

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

- To determine if a 2 x 0,1 ml priming dose results in an acceptable boostability (% of subjects that have boostable rabies antibodies) after 1 year.
- To determine the lowest booster dose (4 x 0,1 ml, or 2 x 0,1 ml) after a 2 x 0,1 ml priming dose needed to induce an acceptable boostability after 1 year.
- A vaccination regimen is considered to have an acceptable boostability if at least 90% of vaccinated subjects would reach a rabies titre of > 0.5 IU/mL 7 days after booster vaccination. This will be assessed by comparing the one-sided 95% confidence interval for the % of boostable subjects with the target value of 90%. If the one-sided 95% confidence interval excludes 90%, an acceptable boostability is considered to be established.

E.2.2

Secondary objectives of the trial

- To assess good protection after primary vaccination and booster vaccination in both treatment groups (day 372). A titer > 3 IU/ml is considered to give good protection.
- To assess long lasting protection after primary vaccination and booster vaccination in both treatment groups (day 372). A titer > 10 IU/ml is considered to give long-lasting immunity.
- To investigate the serological response after the primary vaccination (on day 7) in both treatment groups. A titer ≥ 0,5 IU/ml is considered to be boostable.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

» Willingness to provide written consent
» Seronegative for rabies
» Belgian soldiers or military students who are deployable but not for an high rabies risk area (as land deployment to Africa or Asia)
» Prepared to follow the study schedule

E.4

Principal exclusion criteria

» Subjects who have had rabies vaccination (complete or incomplete) in the past due to post-exposure prophylaxis. Subjects with a known allergy to one of the components of the vaccine.Immune depressed persons or intake of immunodepressant medication.
» Subjects who take mefloquine.
» Planned deployment to overseas areas within 28 days.
» Planned deployment to high rabies risk areas within 2 years; for example (as land deployment to Africa or Asia).

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is the boostability of the rabies antibodies on day 7 after booster vaccination at 1 year after initial vaccination.
A rabies serology value of more than 3 IU/ml on day 7 after booster vaccination is considered to be protective. Subjects showing this serology value at day 7 are considered to be boostable.

E.5.1.1

Timepoint(s) of evaluation of this end point

day 7 after booster vaccination at 1 year after initial vaccination

E.5.2

Secondary end point(s)

- Rabies serology more than 3 IU/ml on day 7 after simulated booster vaccination.
- Rabies serology more than 10 IU/ml on day 7 after simulated booster vaccination.
- The initial long lasting protection (= rabies serology more than 10 IU/ml on day 7 after primary vaccination) after primary vaccination will be determined.
- Rabies serology more than 0,5 IU/ml on day 7 after primary vaccination in both arms.
- Serological response of booster vaccination for non-responders in both arms.
- Adverse events within one week after initial and booster vaccinations and serious adverse event within 14 days after initial and booster vaccinations (as described in section 7).

E.5.2.1

Timepoint(s) of evaluation of this end point

day 7 after simulated booster vaccination
14 days after initial and booster vaccinations

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

Yes

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)

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

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

Yes

E.8.2.3.1

Comparator description

other vaccination schedule with same IMP

E.8.2.4

Number of treatment arms in the trial

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

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

end of trial is defined as the last visit of the last patient

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

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)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

330

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

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

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

330

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

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2014-07-31

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-07-08

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2017-03-27

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