Clinical Trials Register

Summary
EudraCT Number:	2021-002174-52
Sponsor's Protocol Code Number:	APHP210605
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-05-06
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

France - ANSM

A.2

EudraCT number

2021-002174-52

A.3

Full title of the trial

Essai multicentrique randomisé en ouvert comparant l’efficacité immunologique d’un schéma vaccinal combinant deux vaccins ARNm Covid19 (Pfizer-BioNTech et Moderna) à celle d’une vaccination homologue de chaque vaccin ARNm Covid19 : essai de non infériorité

A.3.1

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

A.3.2

Name or abbreviated title of the trial where available

ARNCOMBI

A.4.1

Sponsor's protocol code number

APHP210605

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	Assistance Publique -Hopitaux de Paris
B.1.3.4	Country	France
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	ministere de la santé
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Assistance Publique -Hopitaux de Paris
B.5.2	Functional name of contact point	Fatiha ACED-DJENNAOUI
B.5.3	Address:
B.5.3.1	Street Address	1 avenue Claude Vellefaux, Hopital Saint Louis
B.5.3.2	Town/ city	Paris
B.5.3.3	Post code	75010
B.5.3.4	Country	France
B.5.4	Telephone number	330144841708
B.5.5	Fax number	330144841708
B.5.6	E-mail	fatiha.djennaoui@aphp.fr

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
D.2.1.1.2	Name of the Marketing Authorisation holder	BioNTech Manufacturing GmbH
D.2.1.2	Country which granted the Marketing Authorisation	France
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	COMIRNATY
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	COVID-19 mRNA vaccine (nucleoside-modified)
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
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	COVID-19 vaccine Moderna
D.2.1.1.2	Name of the Marketing Authorisation holder	MODERNA BIOTECH SPAIN, S.L.
D.2.1.2	Country which granted the Marketing Authorisation	France
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	COVID-19 vaccine Moderna
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	COVID-19 mRNA vaccine Moderna (CX-024414)
D.3.9.4	EV Substance Code	SUB207171
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	200
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

COVID19, l’efficacité immunologique d’un schéma vaccinal combinant deux vaccins ARNm Covid19 (Pfizer-BioNTech et Moderna) à celle d’une vaccination homologue de chaque vaccin ARNm

E.1.1.1

Medical condition in easily understood language

covid19, l’efficacité immunologique d’un schéma vaccinal combinant deux vaccins ARNm Covid19 (Pfizer-BioNTech et Moderna) à celle d’une vaccination homologue de chaque vaccin ARNm

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

Evaluer la non infériorité de la réponse immunitaire à 28 jours après la deuxième dose d’une vaccination combinant les deux vaccins ARNm comparativement à celle d’une vaccination standard (deux doses du même vaccin ARNm)

E.2.2

Secondary objectives of the trial

Etudier la réactogénicité selon le schéma vaccinal.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Age ≥ 18 ans
2.Ayant reçu une première dose de l’un des deux vaccins à ARNm (Pfizer-BioNTech ou Moderna) selon les recommandations.
3.Pour lesquels une une 2ème dose de vaccin ARNm est prévue dans un délai de 4 à 6 semaines (selon les recommandation de l’HAS et de l’ANSM).
4.Consentement éclairé signé par le participant et l’investigateur.
5.Personne affiliée à un régime de sécurité sociale.

E.4

Principal exclusion criteria

1. Antécédent d’infection par le COVID-19 documenté par PCR y compris entre les deux doses vaccinales
2. Infection aigue fébrile (température corporelle ≥ 38,0°C) dans les 72 heures précédentes et/ou présentant des symptômes suggérant la présence de COVID-19 ou avoir été cas contact au cours des 14 derniers jours avant la visite d’inclusion.
3. Médicaments immunosuppresseurs tels que les corticostéroïdes à un dosage > 10 mg d'équivalent prednisone /jour (à l'exclusion des préparations topiques et des inhalateurs) dans les 3 mois précédant l’inclusion ou dans les 6 mois pour les chimiothérapies.
4. Traitement par immunoglobulines ou un autre produit sanguin dans les 3 mois précédant l’inclusion ou ayant une administration d’immunoglobulines ou d’un produit sanguin prévue avant la fin de l'étude.
5. Infection connue au VIH, au VHC ou au VHB.
6. Toute pathologie entrainant une immunodépression, tel qu'un cancer, susceptible de réduire la réponse immunitaire.
7. L'utilisation d'Ig expérimentales, d'anticorps monoclonaux expérimentaux ou de sérum de convalescents n'est pas autorisée pendant l'étude.
8. Grossesse ou allaitement en cours.
9. Participation à une autre recherche impliquant la personne humaine (Jardé 1 ou Jardé 2) dans les 4 semaines précédant la visite d’inclusion
10. Personne faisant l’objet d’une mesure de protection juridique (tutelle, curatelle ou mesure de sauvegarde).
11. Réaction d’intolérance grave : allergie grave (angio oedeme, oedeme de Quincke) ou choc anaphylactique lors de la première injection vaccinale

E.5 End points

E.5.1

Primary end point(s)

Titre d’IgG anti Spike mesurées par un test ELISA et d’anticorps neutralisants 28 jours après la deuxième injection

E.5.1.1

Timepoint(s) of evaluation of this end point

28 jours

E.5.2

Secondary end point(s)

Tout effet indésirable, réactions locales et systémiques survenues jusqu’à 28 jours après la deuxième injection

E.5.2.1

Timepoint(s) of evaluation of this end point

jusqu'à 28 jours

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

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

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.8.2.4

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

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	No
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
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	No
F.3.3.1	Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-05-06.	Yes
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	Yes
F.3.3.4	Nursing women	Yes
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	400

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

2021-05-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-05-11

P. End of Trial
P.	End of Trial Status	Ongoing

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