Clinical Trials Register

Summary
EudraCT Number:	2021-005043-71
Sponsor's Protocol Code Number:	EU-COVPT-1
National Competent Authority:	Sweden - MPA
Clinical Trial Type:	EEA CTA
Trial Status:
Date on which this record was first entered in the EudraCT database:	2022-08-23
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

Sweden - MPA

A.2

EudraCT number

2021-005043-71

A.3

Full title of the trial

A Phase 2, Comparative Randomised Trial to Evaluate the impact of
reduced COVID-19 mRNA vaccination regimen on immunological
responses and reactogenicity in paediatric subjects withprior SARS-CoV-2 immunity

A.3.1

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

Clinical Study Evaluating the immune responses and safety of single versus two dose COVID-19 mRNA Vaccination in children (CoVacc)

A.3.2

Name or abbreviated title of the trial where available

Immunogenicity and reactogenicity of reduced COVID-19 mRNA vaccination regimen in children (CoVacc)

A.4.1

Sponsor's protocol code number

EU-COVPT-1

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	University Medical Center Utrecht
B.1.3.4	Country	Netherlands
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	Horizon 2020
B.4.2	Country	European Union
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	University Medical Center Utrecht
B.5.2	Functional name of contact point	EUPG, CoVacc Study Team
B.5.3	Address:
B.5.3.1	Street Address	Heidelberglaan 100
B.5.3.2	Town/ city	Utrecht
B.5.3.3	Post code	3584 CX
B.5.3.4	Country	Netherlands
B.5.6	E-mail	covacc@umcutrecht.nl

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	Comirnaty original
D.2.1.1.2	Name of the Marketing Authorisation holder	BioNTech Manufacturing GmbH
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	Concentrate for dispersion for injection
D.3.4.1	Specific paediatric formulation	Yes
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: 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	Comirnaty Original/Omicron BA.4-5
D.2.1.1.2	Name of the Marketing Authorisation holder	BioNTech Manufacturing GmbH
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	Concentrate for dispersion for injection
D.3.4.1	Specific paediatric formulation	Yes
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.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

Healthy volunteers (paediatric subjects) with prior SARS-CoV-2 infection

E.1.1.1

Medical condition in easily understood language

Healthy children with prior COVID-19 infection

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	10084464
E.1.2	Term	COVID-19 immunization
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

To determine if the humoral immune response of a single compared to a two dose COVID‐19 vaccination regimen is non‐inferior in paediatric subjects who are immunologically primed by natural infection.

E.2.2

Secondary objectives of the trial

1. To assess the safety and reactogenicity profile of a single dose COVID‐19 vaccine regimen
against SARS‐CoV‐2 in paediatric subjects with a history of prior SARS‐CoV‐2 infection,
compared to the two dose regimen.
2. To assess the medium (6 months) and long term (12 month) humoral immune response of
the single COVID‐19 vaccine dosing regimen against wild‐type SARS‐CoV‐2 in paediatric
subjects with a history of prior SARS‐CoV‐2 infection.
3. To assess the short (28 days), medium and long term humoral immune response of the single
dose COVID‐19 vaccine regimen against SARS‐CoV‐2 variants of concern (VoCs) in paediatric subjects with a history of prior SARS‐CoV‐2 infection.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Aged ≥5 years to ≤11 years of age on day of signing the informed consent form.
2. In good health or stable clinical condition.
3. Legally Acceptable Representative (LAR) has reviewed the subject information and signed the informed consent form on behalf of the subject and the subject has expressed willingness to participate.

E.4

Principal exclusion criteria

1. Has previously received any investigational or licensed COVID‐19 vaccine.
2. Has known congenital or acquired immune disorder or immunodeficiency that may interfere
with vaccine response e.g. known infection with human immunodeficiency virus (HIV) with
low CD4 count or other immunosuppression at time of signing informed consent form.
3. Has a history of autoimmune disease or an active autoimmune disease requiring therapeutic
intervention (including systemic glucocorticoids), or findings that may have a significant
effect on the target endpoints and which may therefore mask or inhibit the therapeutic
effect under investigation as judged by the investigator.
4. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection or venepuncture.
5. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction
(eg, anaphylaxis) to any component of the study intervention(s).
6. Receipt of medications intended to prevent COVID‐19.
7. Uses drugs with significant interaction with the investigational product or has any
contraindications as per the Summary of Product Characteristics.
8. Other medical or psychiatric condition or laboratory abnormality that may increase the risk
of study participation or, in the investigator’s judgment, make the participant inappropriate
for the study.
9. Has any kind of dependency on the principal investigator or member of the study team or LAR is employed by the principal investigator or within the same department as the PI or study team at the institution where the study is executed.
10. Is unable to report solicited adverse events.

E.5 End points

E.5.1

Primary end point(s)

The geometric mean ratio of neutralizing
titers against wild type virus (Virus Neutralization Assay) at day 28 after completion of the control
versus the intervention regimen of the vaccine.

E.5.1.1

Timepoint(s) of evaluation of this end point

as specified in the endpoints

E.5.2

Secondary end point(s)

Safety:
- The percentage of subjects reporting at least one solicited systemic adverse events Grade ≥ 2 (AEs) in the 7 days after any vaccine dose, as measure of systemic reactogenicity.
- The percentage of subjects reporting solicited local and systemic adverse events (AEs) for 7 days
after each vaccine dose.
- The percentage of subjects reporting unsolicited AEs for 14 days after each vaccine dose.
- The percentage of subjects reporting serious adverse events (SAEs) Grade ≥ 3 on the Common
Toxicity Criteria or Adverse Events of Special interest (AESI) until 12 months post‐vaccination.

Immunogenicity:
- Neutralizing titers against wild type virus (Virus Neutralization Assay) at 6 and 12 months postvaccination.
- Quantitative enzyme‐linked immunosorbent assay (anti‐RBD‐ELISA) at 28 days, 6 months and 12
months post‐vaccination.
- Geometric Mean Fold Ratio in SARS‐CoV‐2 serum anti‐RBD antibody titer from before vaccination
to each subsequent time points at 1, 6 and 12 months post‐vaccination.
- Neutralizing titers against variants of concern (Virus Neutralization Assay) at day 28 and 6 months
post‐vaccination.

E.5.2.1

Timepoint(s) of evaluation of this end point

as specified in the endpoints

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

Yes

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)

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

Yes

E.8.1.3

Single blind

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

One dose injected verses 2 doses injected with 21-84 days interval

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

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

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.8.9.1

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

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:

200

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:

200

F.1.1.6

Adolescents (12-17 years)

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

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

Children 5 to 11 years of age

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

200

F.4.2.2

In the whole clinical trial

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)

If the study results at completion of the clinical trial show that the humoral immune response of a single dose COVID-19 vaccination in subjects assigned to the single dose intervention arm is insufficient, it will be considered to offer those subjects an additional vaccination following local practices and regulations.

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	VACCELERATE
G.4.3.4	Network Country	Germany

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2022-09-14

Ethics Committee Opinion of the trial application

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

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