Clinical Trials Register

Summary
EudraCT Number:	2021-000566-14
Sponsor's Protocol Code Number:	CoVigi
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:	2021-02-17
Trial 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

2021-000566-14

A.3

Full title of the trial

Post-authorization Phase IV effectiveness and safety multicentric study of COVID-19 vaccines – CoVigi

Poregistrační multicentrická studie fáze IV sledující účinnost a bezpečnost vakcín proti COVID-19 – CoVigi

A.3.1

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

Post-authorization Phase IV effectiveness and safety multicentric study of COVID-19 vaccines – CoVigi

Poregistrační multicentrická studie fáze IV sledující účinnost a bezpečnost vakcín proti COVID-19 – CoVigi

A.4.1

Sponsor's protocol code number

CoVigi

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	Masarykova univerzita
B.1.3.4	Country	Czechia
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	Masarykova univerzita
B.4.2	Country	Czechia
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Masarykova univerzita
B.5.2	Functional name of contact point	Farmakologický ústav LF MU
B.5.3	Address:
B.5.3.1	Street Address	Kamenice 5
B.5.3.2	Town/ city	Brno
B.5.3.3	Post code	625 00
B.5.3.4	Country	Czechia
B.5.6	E-mail	demlova@med.muni.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	VAXZEVRIA
D.2.1.1.2	Name of the Marketing Authorisation holder	AstraZeneca AB, Södertälje, Švédsko
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	No
D.3.7	Routes of administration for this IMP	Intramuscular use
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.IMP: 2
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	SPIKEVAX
D.2.1.1.2	Name of the Marketing Authorisation holder	MODERNA BIOTECH SPAIN, S.L., Madrid, Španělsko
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	Dispersion for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
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: 3
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	COMIRNATY
D.2.1.1.2	Name of the Marketing Authorisation holder	BioNTech Manufacturing GmbH, Mainz, Německo
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	Dispersion for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
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: 4
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	COVID-19 VACCINE JANSSEN
D.2.1.1.2	Name of the Marketing Authorisation holder	Janssen-Cilag International N.V., Beerse
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	No
D.3.7	Routes of administration for this IMP	Intramuscular use
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

COVID-19 Vaccines, monitoring of adverse events and evaluation of the immune response

Vakcíny proti COVID-19, sledování nežádoucích účinků a stanovení imunitní odpovědi

E.1.1.1

Medical condition in easily understood language

COVID-19 Vaccines, monitoring of adverse events and evaluation of the immune response

Vakcíny proti COVID-19, sledování nežádoucích účinků a stanovení imunitní odpovědi

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	23.1
E.1.2	Level	LLT
E.1.2	Classification code	10084465
E.1.2	Term	COVID-19 vaccination
E.1.2	System Organ Class	100000004865

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

1) Post-authorization monitoring of adverse events and effects (data collection based on a questionnaire survey and evaluation by study physician)
• Severity, expectations, intensity, relationship to vaccination
• Nature of adverse event, duration
2) Evaluation of the immune response of vaccinated subjects by determining the level of antibodies and cellular immunity over time
3) Incidence of COVID-19 disease in vaccinated subjects based on information on a positive test for SARS-CoV-2 (clinically symptomatic and asymptomatic disease)

1) Poregistrační sledování nežádoucích příhod a účinků (sběr dat na základě dotazníkového šetření a vyhodnocení zkoušejícím lékařem)
• Závažnost, očekávanost, intenzita, souvislost s vakcinací
• Charakter NÚ, délka trvání
2) Hodnocení imunitní odpovědi vakcinovaných subjektů stanovením hladiny protilátek a buněčné imunity v čase
3) Incidence onemocnění COVID-19 u vakcinovaných subjektů na základě informace o pozitivním testu na SARS-CoV-2 (klinicky symptomatické i asymptomatické onemocnění)

E.2.2

Secondary objectives of the trial

Exploratory: In a subgroup of cancer patients (patients with solid tumors) undergoing active anticancer therapy:
• Monitoring and evaluation of objectives and parametrs mentioned as primary
• Evaluation of the circulating immune profile
• Evaluation of objectives and parameters in connection with the type of cancer treatment administered

Průzkumné cíle: U podskupiny onkologicky nemocných:
• Sledování a vyhodnocení cílů a parametrů uvedených výše jako primární
• Hodnocení cirkulujícího imunitního profilu
• Vyhodnocení cílů a parametrů v souvislosti s druhem podávané onkologické léčby

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1) Age ≥ 18 years
2) Willingness to participate in the study expressed by signing the informed consent form

A subject can be included in a cohort of newly enrolled subjects with an already fully applied vaccination scheme according to SmPC, if they additionally meet the following criteria:
1) Patient in the care of the Department of Internal Hematology and Oncology, University Hospital Brno
2) Planned booster dose (3rd dose for the originally two-dose schedule, or 2nd dose for the single-dose schedule)

1) Věk ≥ 18 let
2) Ochota účastnit se studie vyjádřená podpisem formuláře informovaného souhlasu

Subjekt může být zařazen do kohorty nově zařazených subjektů s již plně aplikovaným očkovacím schématem dle SmPC, pokud navíc splňuje následující kritéria:
1) Pacient v péči Interní hematologické a onkologické kliniky Fakultní nemocnice Brno
2) Plánované přeočkování booster dávkou (3. dávka u původně dvoudávkového schématu, příp. 2. dávka u jednodávkového schématu)

E.4

Principal exclusion criteria

1) Pregnancy, breastfeeding
2) Inadequacy of patient classification based on the individual assessment of the study physician

1) Těhotenství, kojení
2) Nevhodnost zařazení pacienta na základě individuálního posouzení zkoušejícího lékaře

E.5 End points

E.5.1

Primary end point(s)

1) monitoring for adverse events and effects
2) evaluation of the immune response of vaccinated subjects
3) incidence of COVID-19 disease in vaccinated subjects

1) sledování nežádoucích příhod a účinků
2) hodnocení imunitní odpovědi vakcinovaných subjektů
3) incidence onemocnění COVID-19 u vakcinovaných subjektů

E.5.1.1

Timepoint(s) of evaluation of this end point

1) visit 2, 3 and 4
2) baseline (visit 1), visit 2, 3, 4, 5 and 6
3) from first vaccination dose to end of trial

1) návštěva 2, 3 a 4
2) baseline (návštěva 1), návštěva 2, 3, 4, 5 a 6
3) od první dávky vakcíny do konce studie

E.5.2

Secondary end point(s)

Monitoring and evaluation of primary objectives and parameters in a subgroup of cancer patients and evaluation of the circulating immune profile

Sledování a vyhodnocení primárních cílů a parametrů u podskupiny onkologicky nemocných a hodnocení cirkulujícího imunitního profilu

E.5.2.1

Timepoint(s) of evaluation of this end point

End of trial

Konec studie

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

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)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

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

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

LPLV

Poslední vizita posledního pacienta

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:

282

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

283

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

Yes

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

565

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

Žádná

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

2021-02-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-03-17

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2023-11-01

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