Clinical Trials Register

Summary
EudraCT Number:	2021-002530-17
Sponsor's Protocol Code Number:	D7220C00001
National Competent Authority:	Poland - Office for Medicinal Products
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-06-28
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

Poland - Office for Medicinal Products

A.2

EudraCT number

2021-002530-17

A.3

Full title of the trial

A Phase II/III Partially Double-Blinded, Randomised, Multinational, Active-Controlled Study in Both Previously Vaccinated and Unvaccinated Adults to Determine the Safety and Immunogenicity of AZD2816, a Vaccine for the Prevention of COVID-19 Caused by Variant Strains of SARS-CoV-2

A.3.1

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

A Phase 3 study, blinded in vaccinated and unvaccinated adults to determine the safety and immune response of AZD2816, a vaccine for the prevention of COVID-19 caused by variant strains

A.4.1

Sponsor's protocol code number

D7220C00001

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	AstraZeneca AB
B.1.3.4	Country	Sweden
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	AstraZeneca AB
B.4.2	Country	Sweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	AstraZeneca AB
B.5.2	Functional name of contact point	Information Center
B.5.3	Address:
B.5.3.1	Street Address	N/A
B.5.3.2	Town/ city	N/A
B.5.3.3	Post code	N/A
B.5.3.4	Country	Sweden
B.5.6	E-mail	information.center@astrazeneca.com

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
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.3.2	Product code	AZD1222
D.3.4	Pharmaceutical form	Solution 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.3.9.1	CAS number	2420395-83-9
D.3.9.2	Current sponsor code	AZD1222
D.3.9.3	Other descriptive name	ChAdOx1 nCoV-19
D.3.10	Strength
D.3.10.1	Concentration unit	Other
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1 x E11
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)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
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	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.3.2	Product code	AZD2816
D.3.4	Pharmaceutical form	Solution 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.3.9.2	Current sponsor code	AZD2816
D.3.9.3	Other descriptive name	ChAdOx-nCoV19
D.3.10	Strength
D.3.10.1	Concentration unit	Other
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	1 x E11
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)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
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

SARS-COV-2 infection (COVID-19)

E.1.1.1

Medical condition in easily understood language

COVID-19

E.1.1.2

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	23.0
E.1.2	Level	PT
E.1.2	Classification code	10051905
E.1.2	Term	Coronavirus infection
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Previously Unvaccinated Participants Receiving a 2-Dose Primary Vaccination
To characterize the safety and tolerability of a 2-dose primary vaccination with AZD2816 with a 4-week dosing interval in previously unvaccinated seronegative participants.
Previously Vaccinated Participants Receiving a 1-Dose Booster
To characterize the safety and tolerability of 1 booster dose of AZD2816 in participants previously vaccinated with AZD1222.

Immunogenicity objectives: see protocol

E.2.2

Secondary objectives of the trial

Previously Unvaccinated Participants Receiving a 2-Dose Primary Vaccination
- To characterize the safety and tolerability of a heterologous primary vaccination with 1 dose of AZD1222 followed by 1 dose of AZD2816 administered with a 4-week dosing interval in
previously unvaccinated seronegative participants
- To characterize the safety and tolerability of a 2-dose primary vaccination with AZD2816 with a 12-week dosing interval in previously unvaccinated seronegative participants
- To characterize the extended safety of a 2-dose primary vaccination with AZD2816 with a 4-week dosing interval in previously unvaccinated
seronegative participants (see more in protocol)
Previously Vaccinated Participants Receiving a 1-Dose Booster
- To characterize the safety and tolerability of 1 booster dose of AZD1222 in seronegative participants previously vaccinated with AZD1222 (see more in protocol)

Immunogenicity objectives: see protocol

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1 Adult, ≥ 18 years of age at the time of consent

For inclusion in the SARS-CoV-2 seronegative population:

2 No history of laboratory-confirmed SARS-CoV-2 infection (ie, no positive nucleic acid
amplification test and no positive antibody test).
3 Seronegative for SARS-CoV-2 at screening (lateral flow test to detect reactivity to the
nucleoprotein).
4 Medically stable such that, according to the judgment of the investigator, hospitalization
within the study period is not anticipated and the participant appears likely to be able to
remain on study through the end of protocol-specified follow-up
5 Able to understand and comply with study requirements/procedures (if applicable, with
assistance by caregiver, surrogate, or legally authorized representative) based on the
assessment of the investigator
6 Signed informed consent obtained before conducting any study-related procedures
7 Contraceptive use by women should be consistent with local regulations regarding the
methods of contraception for those participating in clinical studies.

Previously COVID-19 Vaccinated Participants
8 Prior completion of a 2-dose primary homologous vaccination regimen against the original SARSCoV-2 Wuhan-hu-1 strain with either AZD1222 (2 standard doses as authorized vaccine or as investigational
product in a clinical trial with a 4 to 12-week dosing interval) or with an mRNA vaccine
approved for emergency or conditional use (eg, BNT162b2 vaccine [Pfizer-BioNTech]
with a 3- to 12-week dosing interval or mRNA-1273 vaccine [Moderna] with a 4- to 12- week dosing interval). The second dose in all cases should have been administered at least 90 days prior to first administration of study intervention.

E.4

Principal exclusion criteria

1 History of allergy to any component of AZD1222/AZD2816.
2 History of Guillain-Barré syndrome, any demyelinating disease, or any other neuroimmunologic condition
3 Significant infection or other acute illness, including fever > 100 °F (> 37.8 °C) on the day prior to or day of randomization
4 Any confirmed or suspected immunosuppressive or immunodeficient state, including asplenia or HIV/AIDS.
5 Recurrent severe infections and use of immunosuppressant medication within the past 6 months (≥ 20 mg per day of prednisone or its equivalent, given daily or on alternate
days for ≥ 15 days within 30 days prior to administration of study intervention). The following exceptions are permitted: Topical/inhaled steroids or short-term oral steroids (course lasting ≤ 14 days)
6 History of primary malignancy (see protocol)
7 History of thrombocytopenia and/or thrombosis, including participants who have experienced major venous and/or arterial thrombosis in combination with thrombocytopenia following vaccination with any COVID-19 vaccine
8 History of heparin-induced thrombocytopenia, congenital thrombophilia (ie, factor V Leiden, prothrombin G20210A, antithrombin III deficiency, protein C deficiency and protein S deficiency, factor XIII mutation, familial dysfibrinogenemia), auto-immune thrombophilia (antiphospholipid syndrome, anti-cardiolipin antibodies, anti-β2- glycoprotein 1 antibodies), or paroxysmal nocturnal haemoglobinuria.
9 Clinically significant bleeding (eg, factor deficiency, coagulopathy, or platelet disorder),
or prior history of significant bleeding or bruising following intramuscular injections or venepuncture
10 Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal
disease, liver disease, renal disease, endocrine disorder, or neurological illness, as judged
by the Investigator (note, mild/moderate well-controlled comorbidities are allowed)
11 Any other significant disease, disorder, or finding that may significantly increase the risk to the participant because of participation in the study, affect the ability of the participant to participate in the study, or impair interpretation of the study data
12 Any autoimmune conditions, except mild psoriasis and vitiligo

E.5 End points

E.5.1

Primary end point(s)

Naďve unvaccinated cohort receiving a 2-dose primary vaccination and
Previously vaccinated cohort receiving a 1-dose booster vaccination
-Incidence of local and systemic solicited AEs for 7 days post-dose
- Incidence of unsolicited AEs, including MAAEs, SAEs, and AESIs, for 28
days post-dose
-The change from baseline for safety laboratory measures for 28 days
post-dose
Immunogenicity endpoints:
for Naďve unvaccinated cohort receiving a 2-dose primary vaccination
-GMT ratio of pseudoneutralizing antibodies for AZD2816
vaccination/AZD1222 Vaccination
For Previously vaccinated cohort receiving a 1-dose booster vaccination:
- GMT ratio of pseudoneutralizing antibodies for AZD2816
booster/AZD1222 vaccination

E.5.1.1

Timepoint(s) of evaluation of this end point

for 7 and 28 days post-dose
for immunogenicity endpoints – 56 days post second dose or 28 days post booster

E.5.2

Secondary end point(s)

- Incidence of local and systemic solicited AEs for 7 days post-dose
- Incidence of unsolicited AEs, including MAAEs, SAEs, and AESIs for 28 days post-dose
- Incidence of MAAEs, SAEs, and AESIs from Day 1 through 6 months post-vaccination

Secondary immunogenicity endpoints:
Both cohorts:
- GMT ratio of pseudoneutralizing antibodies for B.1.351/Wuhan-hu-1
- Difference in seroresponse (>4-fold increase from baseline in
pseudoneutralizing antibodies) against B.1.351 versus Wuhan-hu-1
Naďve unvaccinated cohort receiving a 2-dose primary vaccination
- GMT ratio of pseudoneutralizing antibodies for AZD2816
vaccination/AZD1222 vaccination
-Difference in seroresponse (>4-fold increase from baseline in
pseudoneutralizing antibodies) for AZD2816 vaccination - AZD1222
vaccination
- GMT ratio of pseudoneutralizing antibodies for AZD1222+AZD2816
vaccination/AZD1222 vaccination
-Difference in seroresponse (>4-fold increase from baseline in
pseudoneutralizing
antibodies) for AZD1222+AZD2816 vaccination - AZD1222 vaccination
Previously vaccinated cohort receiving a 1-dose booster vaccination
- GMT ratio of pseudoneutralizing antibodies for AZD2816
booster/AZD1222 booster
- GMT ratio of pseudoneutralizing antibodies for AZD1222
booster/AZD1222 vaccination
- GMT ratio of pseudoneutralizing antibodies for AZD2816
booster/AZD1222 vaccination
- Difference in seroresponse (>4-fold increase from baseline in
pseudoneutralizing antibodies) for AZD2816 booster versus AZD1222
primary vaccination
-Difference in seroresponse (>4-fold increase from baseline in
pseudoneutralizing antibodies) for AZD2816 booster versus AZD1222 booster

E.5.2.1

Timepoint(s) of evaluation of this end point

for 7 and 28 days post-dose until 6 months post vaccination
for immunogenicity objectives - 56 days post-dose (2nd dose), 28 days post booster

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

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

Yes

E.6.13.1

Other scope of the trial description

Immunogenicity

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)

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

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

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

Information not present in EudraCT

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.8.5.1

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

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

South Africa

Brazil

Poland

United Kingdom

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

The end of the study is defined as the date of the last scheduled procedure shown in the Schedule of Activities (Section 1.3) for the last participant in the study globally.

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 months

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:

2137

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

712

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

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

450

F.4.2

For a multinational trial

F.4.2.1

In the EEA

1440

F.4.2.2

In the whole clinical trial

2849

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

2021-07-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-07-14

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2022-08-02

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