Clinical Trials Register

Summary
EudraCT Number:	2020-006051-17
Sponsor's Protocol Code Number:	mRNA-1647-P301
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-11-02
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

Spain - AEMPS

A.2

EudraCT number

2020-006051-17

A.3

Full title of the trial

A Phase 3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Healthy Participants 16 to 40 Years of Age

Estudio de fase 3, aleatorizado, con observador ciego, controlado con placebo para evaluar la eficacia, la seguridad y la inmunogenicidad de la vacuna mRNA-1647 para el citomegalovirus (CMV) en participantes sanos de 16 a 40 años de edad

A.3.1

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

Evaluating the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Healthy Participants 16 to 40 Years of Age

Evaluando la eficacia , la seguridad y la inmunogenicidad de la vacuna mRNA-1647 para el citomegalovirus (CMV) en participantes sanos de 16 a 40 años de edad

A.4.1

Sponsor's protocol code number

mRNA-1647-P301

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	ModernaTX, Inc.
B.1.3.4	Country	United States
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	ModernaTX, Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	ModernaTX, Inc.
B.5.2	Functional name of contact point	Vice President
B.5.3	Address:
B.5.3.1	Street Address	200 Technology Square
B.5.3.2	Town/ city	Cambridge
B.5.3.3	Post code	MA 02139
B.5.3.4	Country	United States
B.5.4	Telephone number	+34 900834223
B.5.6	E-mail	RegistroEspanolDeEstudiosClinicos@druginfo.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	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	mRNA-1647
D.3.4	Pharmaceutical form	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	see D.3.9.3 'Other descriptive name' below
D.3.9.2	Current sponsor code	CX-000667
D.3.9.3	Other descriptive name	mRNA encoding Human cytomegalovirus glycoprotein B
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	62
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	see D.3.9.3 'Other descriptive name' below
D.3.9.2	Current sponsor code	CX-000359
D.3.9.3	Other descriptive name	mRNA encoding Human cytomegalovirus UL128
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	8
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	see D.3.9.3 'Other descriptive name' below
D.3.9.2	Current sponsor code	CX-005128
D.3.9.3	Other descriptive name	mRNA encoding Human cytomegalovirus UL131A
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	8
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	see D.3.9.3 'Other descriptive name' below
D.3.9.2	Current sponsor code	CX-000712
D.3.9.3	Other descriptive name	mRNA encoding Human cytomegalovirus UL130
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	9
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	see D.3.9.3 'Other descriptive name' below
D.3.9.2	Current sponsor code	CX-005282
D.3.9.3	Other descriptive name	mRNA encoding Human cytomegalovirus glycoprotein H
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	53
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	see D.3.9.3 'Other descriptive name' below
D.3.9.2	Current sponsor code	CX-000594
D.3.9.3	Other descriptive name	mRNA encoding Human cytomegalovirus glycoprotein L
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	12
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection
D.8.4	Route of administration of the placebo	Intramuscular use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Prevention of Cytomegalovirus infection

Prevención de infección con Citomegalovirus

E.1.1.1

Medical condition in easily understood language

Prevention of Cytomegalovirus infection

Prevención de infección con Citomegalovirus

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	21.1
E.1.2	Level	PT
E.1.2	Classification code	10072247
E.1.2	Term	Cytomegalovirus immunisation
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

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 demonstrate the efficacy of mRNA-1647 vaccine to prevent primary CMV infection in CMV-seronegative female participants
* To evaluate the safety and reactogenicity of mRNA-1647 vaccine when administered on a 3-dose injection schedule in all participants.

•Demostrar la eficacia de la vacuna de ARNm-1647 para prevenir la infección primaria por CMV en participantes de sexo femenino seronegativas para CMV.
•Evaluar la seguridad y la reactogenicidad de la vacuna de ARNm-1647 cuando se administra en una pauta de 3 dosis inyectables en todos los participantes.

E.2.2

Secondary objectives of the trial

* To evaluate immunogenicity to mRNA-1647 when administered on a 3-dose injection schedule in all participants.
* To evaluate persistence of immunogenicity to mRNA-1647 through 24 months after the third injection in all participants.

•Evaluar la inmunogenicidad de ARNm-1647 cuando se administra en una pauta de 3 dosis inyectables en todos los participantes
•Evaluar la persistencia de la inmunogenicidad a ARNm-1647 hasta 24 meses después de la tercera inyección en todos los participantes

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

"A Substudy of Infant Outcomes in Participants who Become Pregnant During Participation in mRNA-1647-P301." mRNA-1647-P301a Substudy is included in the Protocol. The aim of the substudy is to assess cytomegalovirus (CMV)-related outcomes in live births of female participants who become pregnant during the course of the mRNA-1647-P301 main study. All objectives and endpoints in this substudy are exploratory.

"Un subestudio de los resultados de los bebés en participantes que quedan embarazadas durante su participación en el ARNm-1647-P301".
El subestudio mRNA-1647-P301a se incluye en el Protocolo. El objetivo del subestudio es evaluar los resultados relacionados con el citomegalovirus (CMV) en los nacidos vivos de mujeres participantes que quedan embarazadas durante el estudio principal mRNA-1647-P301. Todos los objetivos y criterios de valoración de este subestudio son exploratorios.

E.3

Principal inclusion criteria

Inclusion Criteria
Participants are eligible to be included in the study only if all the following criteria apply (no protocol exemptions will be allowed in this study):
1. Is a female and 16 to 40 years of age, at the time of consent.
2. According to the assessment of the Investigator, is in good general health and is capable of complying with study procedures.
3. For female participants aged ≥ 20 years, has or anticipates having direct exposure (in the home, socially, or occupationally) to at least 1 child ≤ 5 years of age. Direct exposure is defined as either a) participant is the parent, or b) participant has close contact (feeding, diaper changes, childcare/supervision) for at least 8 hours per week.
4. For the CMV-seronegative Cohorts: at the Screening visit, is CMV IgG-negative and CMV immunoglobulin M (IgM)-negative; For CMV-seropositive Cohorts: at the Screening visit, is CMV IgG-positive and CMV IgMnegative, or CMV IgG-positive and CMV IgM-positive.
5. Participants with an isolated positive result for CMV IgM (ie, CMV IgG-negative and CMV IgM-positive) will not be eligible for enrollment but may be rescreened after at least 6 weeks from the initial CMV screening Participants (and parent/LAR, if applicable) provides written informed consent/assent.
Participants under the age of majority (ie, under legal age) at the time of enrollment must provide written informed consent at the next study visit once turning the age of majority.
6. Investigator assessment confirms that the participant (including in the case of an emancipated minor), or parent(s)/LAR(s), as applicable, understands and is willing and physically able to comply with protocol-mandated follow-up including all study visits and procedures anticipated during the 30-month study period.
7. Has a body mass index of 15 - 35 kg/m2, inclusive.
8. Female participants: Urine pregnancy test is negative at Screening and negative on the day of the first injection (Day 1).
9. Female participants: If the participant is sexually active with men, all of the following criteria must be met:
• Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection (Day 1).
• Agrees to continue adequate contraception through 3 months following the third study injection (Month 9/Day 257).
Adequate contraception is defined as consistent and correct use of an approved contraceptive method in accordance with the product label, or sterilization of a monogamous male partner prior to study enrollment.

Criterios de inclusión:
Los participantes serán elegibles para ser incluidos en el estudio solo si cumplen todos los siguientes criterios (en este estudio, no se permitirán excepciones al protocolo):
1.Ser Mujer y entre 16 y 40 años de edad en el momento de dar su consentimiento.
2.Según la evaluación del investigador, tener un buen estado de salud general y ser capaz de cumplir con los procedimientos del estudio.
3.Para las participantes de sexo femenino de ≥20 años de edad, estar expuestas directamente (en el entorno familiar, social o laboral) a al menos 1 niño de ≤5 años de edad, o prever dicha exposición. La exposición directa se define como: a) el participante es el progenitor o b) el participante tiene contacto cercano (alimentación, cambios de pañal, cuidado/supervisión infantil) durante al menos 8 horas a la semana.
4.Para las cohortes seronegativas para CMV: en la visita de selección, ser IgG negativo para CMV e IgM negativo para CMV.
Para las cohortes seropositivas para CMV: en la visita de selección, ser IgG positivo para CMV e IgM negativo para CMV, o IgG positivo para CMV-IgG e IgM positivo para CMV. Los participantes con un resultado positivo aislado de IgM para CMV (es decir, IgG negativo para CMV e IgM positivo para CMV) no serán aptos para la inscripción, pero podrán volver a someterse a la selección transcurridas al menos 6 semanas desde la selección inicial para CMV.
5.El participante (y el progenitor/RL, si procede) aporta el consentimiento/asentimiento informado por escrito. Los participantes menores de edad (es decir, en términos legales) en el momento del reclutamiento deben proporcionar el consentimiento informado por escrito en la siguiente visita del estudio tras haber alcanzado la mayoría de edad.
6.La evaluación del investigador confirma que el participante (incluso en los casos de menores emancipados) o el/los progenitor(es)/RL, según corresponda, entiende, está dispuesto y es capaz físicamente de cumplir con el seguimiento exigido por el protocolo, incluidas todas las visitas y procedimientos del estudio previstos durante el periodo de duración de 30 meses.
7.Tener un índice de masa corporal de 15 ‐ 35 kg/m2, inclusive.
8.Participantes de sexo femenino: La prueba de embarazo en orina es negativa en la selección y negativa el día de la primera inyección (día 1).
9.Participantes de sexo femenino: Si la participante es sexualmente activa con hombres, se deben cumplir todos los criterios siguientes:
• Ha utilizado un método anticonceptivo adecuado o se ha abstenido de realizar todas las actividades que podrían dar lugar a un embarazo durante al menos 28 días antes de la primera inyección (día 1).
• Está de acuerdo en continuar con la anticoncepción adecuada durante 3 meses después de la tercera inyección del estudio (día 257/mes 9)Un método anticonceptivo adecuado se define como el uso correcto y sistemático de un método anticonceptivo aprobado de acuerdo con la ficha técnica del producto, o la esterilización de una pareja masculina monógama antes de la inscripción en el estudio.

E.4

Principal exclusion criteria

Exclusion Criteria
Participants eligible for the study must not meet any of the following criteria:
1. Female participants: Is of non-childbearing potential. Non-childbearing potential is defined as one of the following:
• Surgically sterile (reports history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy).
• Postmenopausal state (reports history of amenorrhea for ≥ 12 consecutive months prior to Screening without an alternative medical cause).
2. History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures, Clinically unstable is defined as a diagnosis or condition requiring significant changes in management or medication within the 2 months prior to screening, and includes ongoing workup of an undiagnosed illness that could lead to a new diagnosis or condition. This includes but is not limited to::
• Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, or immune-mediated disease.
• Dermatologic conditions that could affect local solicited AR assessments (eg, tattoos; psoriasis patches affecting skin over the deltoid areas).
• Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of the mRNA-1647 vaccine or any components of the mRNA-1647 vaccine.
• Reported history of bleeding disorder that is considered a contraindication to IM injection or phlebotomy.
• Any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.
3. Received or plans to receive any nonstudy vaccine < 28 days prior to or after any study injection. any study injection; in addition, the following criteria for COVID-19 and influenza vaccines apply:
• Any COVID-19 vaccination series must have been completed a minimum of 28 days prior to receiving any dose of the study injection.
• COVID-19 vaccines (regardless of manufacturer) must be administered at least 28 days prior to or after any study injection.
• Influenza vaccines may be administered > 14 days prior to or after any study injection.
4. Received systemic immunosuppressants or immune-modifying drugs for > 14 days in total within 6 months prior to the day of first injection (Day 1) (for corticosteroids, ≥ 5 mg/day of prednisone equivalent) or plans to do so during the course of the study. Inhaled, nasal, and topical steroids are allowed.
5. Receipt of an antiviral with activity against CMV (ganciclovir, valganciclovir, foscarnet, cidofovir, letermovir, acyclovir, valacyclovir) < 2 weeks prior to the day of first injection or plans to do so during the course of the study.
6. Previous receipt of an investigational CMV vaccine.
7. Receipt of systemic immunoglobulins or blood products < 3 months prior to the day of first injection.
8. Has donated ≥ 450 mL of blood products < 28 days prior to Screening.
9. Participated in an interventional clinical study < 28 days prior to the day of first injection (Day 1) or plans to do so while enrolled in this study.
10. Is a member of study team or is an immediate family member or household member of study personnel.

Criterios de Exclusion:
Los participantes aptos para el estudio no deben cumplir ninguno de los siguientes criterios:
1.Participantes de sexo femenino: No está en edad fértil. No estar en edad fértil se define como una de las siguientes situaciones:
•Esterilidad quirúrgica (notificación de antecedentes de ligadura de trompas bilateral, ovariectomía bilateral, histerectomía).
•Estado posmenopáusico (notificación de antecedentes de amenorrea durante ≥12 meses consecutivos antes de la selección sin una causa médica alternativa).
2.Antecedentes de diagnóstico o afección que, a juicio del investigador, sea clínicamente inestable o pueda afectar a la seguridad de la participante, la evaluación de los criterios de valoración de la seguridad, la evaluación de la respuesta inmunitaria o el cumplimiento de los procedimientos del estudio, que incluyen:
•Antecedentes notificados de inmunodeficiencia congénita o adquirida, afección inmunodepresora o enfermedad de mediación inmunitaria.
•Afecciones dermatológicas que podrían afectar a las evaluaciones de RA locales solicitadas (p. ej., tatuajes, parches para la psoriasis que afecten a la piel en la zona deltoidea).
•Antecedentes notificados de anafilaxia o reacción de hipersensibilidad grave después de recibir la vacuna de ARNm‐1647 o cualquier componente de dicha vacuna.
•Antecedentes notificados de trastorno hemorrágico que se considere una contraindicación a la inyección intramuscular o flebotomía.
•Cualquier afección médica, psiquiátrica u ocupacional, incluidos los antecedentes notificados de drogadicción o alcoholismo, que, en opinión del investigador, pueda suponer un riesgo adicional debido a la participación en el estudio o pueda interferir con la interpretación de los resultados del estudio.
3.Haber recibido o planear recibir cualquier vacuna que no sea del estudio <28 días antes o después de cualquier inyección del estudio; Además, se aplican los siguientes criterios para COVID-19 y vacunas contra la influenza:
• Cualquier serie de vacunación COVID-19 debe haberse completado un mínimo de 28 días antes de recibir cualquier dosis de la inyección del estudio.
• Las vacunas COVID-19 (independientemente del fabricante) deben administrarse al menos 28 días antes o después de cualquier inyección del estudio.
• Las vacunas contra la influenza se pueden administrar> 14 días antes o después de cualquier inyección del estudio.
4.Haber recibido inmunodepresores sistémicos o fármacos modificadores del sistema inmunitario durante >14 días en total en los 6 meses anteriores al día de la primera inyección (día 1) (para corticoesteroides, >5 mg/día de equivalente de prednisona) o tener previsto hacerlo durante el transcurso del estudio. Se permiten corticoesteroides inhalados, nasales y tópicos.
5.Recepción de un antivíral con actividad contra el CMV (ganciclovir, valganciclovir, foscarnet, cidofovir, letermovir, aciclovir, valaciclovir) en <2 semanas anteriores al día de la primera inyección o planes de hacerlo durante el transcurso del estudio.
6.Recepción previa de una vacuna en investigación contra el CMV.
7.Recepción de inmunoglobulinas sistémicas o hemoderivados <3 meses antes del día de la primera inyección.
8.Haber donado ≥450 ml de hemoderivados <28 días antes de la selección.
9.Haber estado en un estudio clínico intervencionista <28 días antes del día de la primera inyección (día 1) o tener previsto hacerlo mientras participa en este estudio.
10. Ser miembro del personal del estudio o familiar directo (o conviviente) del algún miembro del personal del estudio.

E.5 End points

E.5.1

Primary end point(s)

1. Primary CMV infection, defined as seroconversion from a negative to a positive result
for serum IgG as measured by a platform-based automated immunoassay based on at least 1 of the 4 recombinant CMV antigens not encoded by mRNA-1647 (pp150, pp28, pp52, pp38) assessed starting 28 days after the third injection.
2. Solicited ARs through 7 days after each injection, unsolicited AEs through 28 days after each injection, MAAEs from Day 1 through 6 months after the last injection, AESIs from Day 1 through EOS, and SAEs from time of consent through EOS.

1. Infección primaria por CMV, definida como seroconversión de un resultado negativo a uno positivo para IgG sérica medida en una plataforma de inmunoensayo automatizado basado en al menos 1 de los 4 antígenos recombinantes de CMV no codificados por ARNm-1647 (pp150, pp28, pp52, pp38) evaluados a partir de los 28 días siguientes a la tercera inyección.
2. RA solicitadas hasta 7 días después de cada inyección, AA notificados espontáneamente hasta 28 días después de cada inyección, AAAM desde el día 1 hasta 6 meses después de la última inyección, AAEI desde el día 1 hasta el FDE y AAG desde el momento del consentimiento hasta el FDE

E.5.1.1

Timepoint(s) of evaluation of this end point

1. Screening, Day 1, Day 57/M2, Day 85/M3, Day 169/M6, Day 197/M7, Day 287/M10,
Day 347/M12, Day 437/M15, Day 527/M18, Day 617/M21, Day 707/M24, Day 797/M27,
Day 887/M30 (EOS)
2. Solicited ARs through 7 days after each injection, unsolicited AEs through 28 days after each injection, MAAEs from Day 1 through 6 months after the last injection, AESIs from Day 1 through EOS, and SAEs from time of consent through EOS; SAEs from time of consent through EOS; pregnancy safety and outcome data for pregnancies reported from Day 1 to EOS. AEs leading to withdrawal/study discontinuation – from Day 1 through EOS.

1. Selección, día 1, día 57/M2, día 85/M3, día 169/M6, día 197/M7, día 287/M10, día 347/M12, día 437/M15, día 527/M18, día 617/M21, día 707/M24, día 797/M27, día 887/M30 (FDE)
2. RA solicitadas hasta 7 días después de cada inyección, AA notificados espontáneamente hasta 28 días después de cada inyección, AAAM desde el día 1 hasta 6 meses después de la última inyección, AAEI desde el día 1 hasta el FDE y AAG desde el momento del consentimiento hasta el FDE.; datos de seguridad y desenlace del embarazo para los embarazos notificados desde el día 1 hasta el FDE. AA que provocan la retirada/discontinuación del estudio: desde el día 1 hasta el FDE.

E.5.2

Secondary end point(s)

* Antigen-specific nAb and binding antibody GMTs on Day 1, Month 3, Month 7, and Month 12.
* Antigen-specific nAb and binding antibody GMTs on Month 18, Month 24, and Month 30.

AcN específicos de antígenos y MGT de los anticuerpos de unión el día 1 y los meses 3, 7 y 12.
AcN específicos de antígenos y MGT de los anticuerpos de unión los meses 18, 24 y 30.

E.5.2.1

Timepoint(s) of evaluation of this end point

1. Day 1, Day 85/M3, Day 197/M7 and Day 347/M12
2. Day 527/M18, Day 707/M24, and Day 887/M30 (EOS)

1. Día 1, día 85/M3, día 197/M7 y día 347/M12
2. Día 527/M18, día 707/M24 y día 887/M30 (FDE)

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

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

Inmunogenicidad

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

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

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

Yes

E.8.1.7.1

Other trial design description

Observador ciego

Observer-Blind

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

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

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

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

Australia

Canada

Israel

United States

Belgium

Estonia

Finland

France

Germany

Italy

Spain

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

LVLS

UPUV

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

E.8.9.2

In all countries concerned by the trial days

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:

400

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)

Yes

F.1.1.6.1

Number of subjects for this age range:

400

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

6500

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

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

Yes

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

133

F.4.2

For a multinational trial

F.4.2.1

In the EEA

1157

F.4.2.2

In the whole clinical trial

6900

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)

Not applicable for a vaccine/prophylaxis study

No aplicable para un estudio de vacunación / profilaxis

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

2021-12-28

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-12-20

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

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Select Trial Status:	Select Trial Phase:
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Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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