Clinical Trials Register

Summary
EudraCT Number:	2016-004934-11
Sponsor's Protocol Code Number:	TeVaTri042017
National Competent Authority:	Czechia - SUKL
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2017-01-24
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

Czechia - SUKL

A.2

EudraCT number

2016-004934-11

A.3

Full title of the trial

A single blind, randomized comparative and multicentre clinical trial of the immunogenicity and safety of booster immunisation with tetanus monovalent vaccines VACTETA 40 IU/0,5 ml (BIODRUG) and TETAVAX (Sanofi Pasteur SA) in healthy adults.

Jednoduše zaslepené, randomizované, komparativní a multicentrické klinické hodnocení imunogenity a bezpečnosti booster imunizace s tetanovou monovalentní vakcínou VACTETA 40 IU/0,5 ml (BIODRUG) a TETAVAX (Sanofi Pasteur) u zdravých dospělých.

A.3.1

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

Comparative study of immune response and safety of booster immunisation with two tetanus vaccines (Vacteta and Tetavax) in health adults.

Srovnávací studie imunitní odpovědi a bezpečnosti posilujícího očkování dvěma tetanovými vakcínami (Vacteta a Tetavax) u zdravých dospělých.

A.3.2

Name or abbreviated title of the trial where available

Immunogenicity and safety of tetanus vaccine Vacteta 40 IU/0.5 ml in health adults

Imunogenita a bezpečnost tetanové monovakcíny Vacteta 40 IU/0,5 ml u zdravých dospělých

A.4.1

Sponsor's protocol code number

TeVaTri042017

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	BIODRUG s.r.o.
B.1.3.4	Country	Slovakia
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	BIODRUG s.r.o.
B.4.2	Country	Slovakia
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	RECLINMED s.r.o.
B.5.2	Functional name of contact point	Clinical Trial Information Desk
B.5.3	Address:
B.5.3.1	Street Address	Průběžná 41/387
B.5.3.2	Town/ city	Prague 10
B.5.3.3	Post code	100 87
B.5.3.4	Country	Czech Republic
B.5.4	Telephone number	+420608 881 826
B.5.6	E-mail	info@reclinmed.cz

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	Vacteta 40 IU/0.5 ml
D.2.1.1.2	Name of the Marketing Authorisation holder	BIODRUG s.r.o.
D.2.1.2	Country which granted the Marketing Authorisation	Czech Republic
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	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Tetani anatoxinum
D.3.9.3	Other descriptive name	TETANUS TOXOID ADSORBED
D.3.9.4	EV Substance Code	SUB12609MIG
D.3.10	Strength
D.3.10.1	Concentration unit	IU/ml international unit(s)/millilitre
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	80
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	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	Tetavax
D.2.1.1.2	Name of the Marketing Authorisation holder	Sanofi Pasteur SA
D.2.1.2	Country which granted the Marketing Authorisation	Czech Republic
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	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Tetani anatoxinum
D.3.9.3	Other descriptive name	TETANUS TOXOID ADSORBED
D.3.9.4	EV Substance Code	SUB12609MIG
D.3.10	Strength
D.3.10.1	Concentration unit	IU/ml international unit(s)/millilitre
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	80
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

Verification of immune response after booster immunisation with one dose of tetanus monovalent vaccine

Ověření imunitní odpovědi po booster imunizaci s jednou dávkou monovalentní tetanové vakcíny

E.1.1.1

Medical condition in easily understood language

Verification of immune response after booster immunisation with one dose of tetanus vaccine

Ověření imunitní odpovědi po booster imunizaci s jednou dávkou tetanové vakcíny

E.1.1.2

Therapeutic area

Body processes [G] - Immune system processes [G12]

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

Evaluation of immunogenicity of tetanus monovalent vaccine Vacteta after booster immunisation of health adults compared with that induced by vaccine Tetavax.

Zhodnocení imunogenity tetanové monovakcíny Vacteta na základě booster imunizace zdravých dospělých osob oproti imunogenitě dosažené s vakcínou Tetavax.

E.2.2

Secondary objectives of the trial

Evaluation of safety after booster immunisation with tetanus monovalent vaccine Vacteta.

Zhodnocení bezpečnosti booster imunizace tetanové monovakcíny Vacteta.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Subjects must have signed an approved informed consent after complete information
2. Subjects must have written confirmation on previous immunisation against tetanus not older than 15.9 years and not younger than 9.9 years
3. Men and women aged 24.1- 64.9 years.

1. Informovaný souhlas dobrovolně podepsaný po úplné informaci subjektu.
2. Subjekt s písemným potvrzením o předešlém očkování proti tetanu, ne starším než 15,9 let a ne mladším než 9,9 let.
3. Muži i ženy ve věku 24,1 – 64,9 let.

E.4

Principal exclusion criteria

1. Subject without written confirmation of previous vaccination against tetanus, no older than 15.9 years, and not younger than 9.9 years.
2. Subject with acute infectious diseases.
3. Subjects under 24 years of age or older than 65 years, inclusive.
4. Subject allergic to any of the substances of the investigational medicinal product administered in clinical trial (i.e., test and comparator tetanus vaccine).
5. Subject with Guillain-Barré syndrome or neuropathy, an anaphylactic or other allergic reactions after previous vaccination against tetanus.
6. Pregnant woman and breastfeeding (anamnestically).
7. Subject with primary or secondary immunodeficiency (e.g. congenital immunodeficiency, HIV infection, organ or bone marrow transplantation, leukaemia, lymphoma, Hodgkin's disease, multiple myeloma, generalised malignancy, drugs or other causes induced imunodefiency).
8. Subject with progressive or unstable neurological disorder.
9. Subject with severe thrombocytopenia or any coagulation disorder not allowing the intramuscular use.
10. Subject with blood product treatment, including immunoglobulins within the last 90 days prior to study entry.
11. Subject vaccinated less than 30 days inactivated or live vaccine prior to study entry.
12. Participants, who may become pregnant and will take at least a reliable method of contraception during the trial and until its completion.
Reliable contraceptive method (ie. methods that can achieve a failure rate of less than 1% per year), reliable contraceptive methods are: progestogen only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action, male or female condom with or without spermicide, cap, diaphragm or sponge with spermicide. Participants may also use contraceptive methods with a low failure rate, such as combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal, progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner, sexual abstinence (if it corresponds with the preferred and usual lifestyle of participants - but periodic abstinence [eg. by calendar or ovulation], and intermittent contact methods are not acceptable contraceptive methods), bilateral tubal occlusion or partner who had a vasectomy with documented aspermia.
13. Subject incapable of cooperation, incompetent.
14. Subject addicted to alcohol, drugs.
15. Subject unwilling to sign an informed consent.
16. Subject currently participating in another clinical trial or in drug evaluation, within 4 weeks prior to study entry.
17. Dependents (eg soldiers, persons dependent on the researcher - such as subordinates, family members).
18. Subject requiring vaccination against tetanus after injury.

1. Subjekt bez písemného potvrzení o předešlém očkování proti tetanu, ne starším než 15,9 let a ne mladším než 9,9 let.
2. Subjekt s akutním infekčním onemocněním.
3. Subjekt mladší 24 let nebo starší 65 let, včetně.
4. Subjekt alergický na některou ze složek klinicky hodnocené a/nebo referenční vakcíny.
5. Subjekt s Guillain-Barré syndromem nebo neuropatií, s anafylaktickou nebo jinou alergickou reakcí po předešlém očkování proti tetanu.
6. Gravidní žena a žena v laktaci (anamnesticky).
7. Subjekty s primární či sekundární imunodeficiencí (např. vrozená imunodeficience, HIV infekce, orgánová transplantace nebo transplantace kostní dřeně, leukemie, lymfom, Hodgkinova choroba, mnohočetný myelom, generalizovaná malignita, léky či jinou příčinou navozená imunodeficience).
8. Subjekt s progresivní nebo nestabilní neurologickou poruchou.
9. Subjekt se závažnou trombocytopenií nebo poruchou koagulace, které brání intramuskulárnímu podání vakcíny.
10. Subjekt s léčbou krevními deriváty, včetně imunoglobulinů v posledních 90 dnech před vstupem do studie.
11. Subjekt, který byl očkován před méně než 30 dny inaktivovanou nebo živou vakcínou před vstupem do studie.
12. Účastnice, které mohou otěhotnět a nebudou užívat alespoň spolehlivou antikoncepční metodu během klinického hodnocení a až do jeho ukončení.
Spolehlivá antikoncepční metoda (tj. metodu s výskytem těhotenství vyšším než 1 % na jeden rok), spolehlivými antikoncepčními metodami jsou: samotná progestogen orální antikoncepce, kde ale není primárním mechanismem inhibice ovulace, ženský nebo mužský kondom se spermicidem, klobouček, diafragma nebo houbička se spermicidem. Účastnice samozřejmě mohou použít i antikoncepční metody s nízkou mírou selhání, jako je kombinace hormonální antikoncepce spojené s inhibicí ovulace (perorální, intravaginální a transdermální), hormonální antikoncepce pouze s progestogenem spojená s inhibicí ovulace (perorální, injekční a implantační), nitroděložní tělíska (IUD), intrauterinní systém uvolňující hormony, naprostá sexuální abstinence (pokud to odpovídá preferovanému a obvyklému životnímu stylu účastnice – avšak periodická abstinence [např. podle kalendáře nebo ovulace] a metody přerušovaného styku nejsou přijatelné antikoncepční metody), bilaterální tubární okluze, nebo partner, který podstoupil vasektomii s dokumentovanou aspermií po výkonu.
13. Subjekt neschopný spolupráce, nesvéprávný.
14. Subjekt závislý na alkoholu, drogách.
15. Subjekt neochotný podepsat informovaný souhlas.
16. Subjekt současně účastnící se jiného klinického hodnocení léčiva či hodnocení, které se konalo v uplynulých 4 týdnech.
17. Závislé osoby (např. vojáci v základní službě, osoby závislé na výzkumníkovi – např. podřízení, rodinní příslušníci).
18. Subjekt vyžadující očkování proti tetanu po úrazu.

E.5 End points

E.5.1

Primary end point(s)

The primary measurement is the concentration of antibodies specific against tetanus. The primary endpoint will be seroconversion, ie. the proportion of subjects complying the positive criteria of seroconversion. The seroconversion rules are defined as followed: for pre-vaccination levels ≤0.1 IU/ml the post-vaccination levels must increase at least 4-fold and must be higher than 0.4 IU/ml; for prevaccination levels higher than 0.1 IU/ml the post-vaccination levels must increase at least 4-fold.

Primární měřená veličina je koncentrace protilátek specifických vůči tetanu. Primární veličina bude sérokonverze, tj. proporce subjektů, které budou mít po očkování dosaženou pozitivní sérokonverzi. Ta je definována následovně: pro pre-vakcinační hladiny ≤0.1 IU / ml se musí hladiny po očkování zvýšit alespoň 4 krát a musí být vyšší než 0,4 IU / ml; pro pre-vakcinační hladiny vyšší než 0,1 IU / ml se musí hladiny po očkování zvýšit alespoň 4násobně.

E.5.1.1

Timepoint(s) of evaluation of this end point

Before vaccine administration at the same day (V1) and 28 days after vaccine administration (V2).

Před podáním vakciny ve stejný den (V1) a 28 dní po podání vakcíny (V2).

E.5.2

Secondary end point(s)

The secondary endpoints are the geometric mean of antibodies specific against tetanus and proportions of adverse events.

Sekundární veličina bude geometrický průměr protilátek specifických vůči tetanu a proporce nežádoucích příhod.

E.5.2.1

Timepoint(s) of evaluation of this end point

Before vaccine administration at the same day (V1) and 28 days after vaccine administration (V2). Adverse event will be monitored within 30 minutes and within the following 28 days after immunisation.

Před podáním vakciny ve stejný den (V1) a 28 dní po podání vakcíny (V2). Nežádoucí příhody budou sledovány během prvních 30 minut po očkování a následujících 28 dní.

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

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

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)

E.7.4

Therapeutic use (Phase IV)

Yes

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

Yes

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

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in 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

LVLS

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:

200

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

200

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

Žádné

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2017-03-02

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-02-08

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2017-05-29

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IMP with orphan designation in the indication
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