Clinical Trials Register

Summary
EudraCT Number:	2021-000357-26
Sponsor's Protocol Code Number:	214709
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Temporarily Halted
Date on which this record was first entered in the EudraCT database:	2021-06-23
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

Spain - AEMPS

A.2

EudraCT number

2021-000357-26

A.3

Full title of the trial

A Phase III, observer-blind, randomized, multi-country study to evaluate the lot-to-lot consistency of GSK’s investigational RSV maternal vaccine and the immune response, safety and reactogenicity of RSV maternal vaccine when co-administered with GSK’s quadrivalent influenza D-QIV vaccine in healthy non-pregnant women 18-49 years of age.

Estudio fase III, observador-ciego, aleatorizado, internacional para evaluar la consistencia de lotes de la vacuna candidata de GSK para inmunización materna frente al VRS, así como, la respuesta inmune, seguridad y reactogenicidad de esta vacuna candidata de GSK frente al VRS en coadministración con la vacuna tetravalente D-QIV de GSK frente a gripe, en mujeres sanas no embarazadas de 18 a 49 años de edad.

A.3.1

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

A Phase III study to assess the lot-to-lot consistency of GSK’s investigational RSV maternal vaccine and the immune response and safety of RSV maternal vaccine when given alone or co-administered with GSK’s influenza D-QIV vaccine in healthy non-pregnant women.

Estudio de fase III para evaluar la consistencia de lotes de la vacuna candidata de GSK para la inmunización materna y la respuesta inmunitaria, la seguridad y la reactogenicidad de esta vacuna candidata de GSK frente a VRS en coadministración con la vacuna tetravalente D-QIV de GSK frente a gripe, en mujeres sanas no embarazadas de 18 a 49 años de edad.

A.3.2

Name or abbreviated title of the trial where available

RSV MAT-010

A.4.1

Sponsor's protocol code number

214709

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	GlaxoSmithKline S.A.
B.1.3.4	Country	Spain
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	GlaxoSmithKline Biologicals
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	GlaxoSmithKline S.A.
B.5.2	Functional name of contact point	CENTRO DE INFORMACIÓN
B.5.3	Address:
B.5.3.1	Street Address	c/ Severo Ochoa, 2
B.5.3.2	Town/ city	TRES CANTOS (MADRID)
B.5.3.3	Post code	28760
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34902202700
B.5.5	Fax number	+34918070479
B.5.6	E-mail	es-ci@gsk.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.3.1	Product name	RSV MAT
D.3.2	Product code	GSK3888550A
D.3.4	Pharmaceutical form	Powder and solvent for 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.3.8	INN - Proposed INN	NA
D.3.9.3	Other descriptive name	GSKVx000000017076
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	120
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	Influsplit Tetra/Fluarix Tetra
D.2.1.1.2	Name of the Marketing Authorisation holder	GlaxoSmithKline GmbH & Co. KG
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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 in pre-filled syringe
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	NA
D.3.9.3	Other descriptive name	Influenza A virus, A/Victoria/2570/2019 (H1N1)pdm09 - like strain (A/Victoria/2570/2019, IVR-215), Inactivated
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	30
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	NA
D.3.9.3	Other descriptive name	Influenza A virus, A/Cambodia/e0826360/2020 (H3N2) - like strain (A/Tasmania/503/2020, IVR-221), Inactivated
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	30
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	NA
D.3.9.3	Other descriptive name	B/Washington/02/2019 - like virus (B/Washington/02/2019, wild type)
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	30
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	NA
D.3.9.3	Other descriptive name	B/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE)
D.3.9.4	EV Substance Code	SUB178474
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	30
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 (prevention of RSV-associated lower respiratory tract illnesses (LRTIs))

Voluntarios sanos (prevención de VRS. asociado a enfermedades del tracto respiratorio inferior (LRTI))

E.1.1.1

Medical condition in easily understood language

RSV is a very common virus that leads to mild, cold-like symptoms in adults and children. RSV can cause more serious disease in infants, such as inflammation of the lungs.

El VRS es un virus muy común que provoca síntomas leves similares a los de un resfriado en adultos y niños. El VSR puede causar enfermedades más graves en los bebés, como inflamación de los pulmones.

E.1.1.2

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

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

• To evaluate the safety and reactogenicity of RSV MAT vaccine when given alone (pooled lots) or co-administered with Flu D-QIV vaccine up to Day 31 post administration.
• To demonstrate the lot-to-lot consistency of 3 lots of the investigational RSV MAT vaccine based on Geometric mean concentration (GMC) of RSV MAT IgG ELISA at Day 31.
• To demonstrate non-inferiority of Flu D-QIV vaccine when co-administered with RSV MAT vaccine compared to Flu D-QIV vaccine given alone based on Geometric mean titer (GMT) of Flu D QIV antibody titers against 4 influenza strains at Day 31 post administration.

•Evaluar la seguridad y la reactogenicidad de la vacuna RSV MAT hasta el día 31 después de la administración, cuando se administra sola (lotes agrupados) o cuando se coadministra con la vacuna Flu D-QIV.
•Demostrar la consistencia de 3 lotes de la vacuna experimental RSV MAT basándose en las concentraciones medias geométricas (GMC) de IgG anti-RSV MAT (ELISA) en el día 31
•Demostrar la no inferioridad de la vacuna Flu D-QIV en el día 31 después de la administración, cuando se coadministra con la vacuna RSV MAT en comparación con Flu D-QIV sola, basándose en los títulos medios geométricos (GMT) de anticuerpos frente a las 4 cepas de la gripe de Flu D-QIV

E.2.2

Secondary objectives of the trial

•Evaluate the safety of RSV MAT given alone and co-administered with Flu D-QIV from vaccination up to study end
•Demonstrate the non-inferiority of:
oRSV MAT vaccine co-administered with Flu D-QIV compared to given alone based on GMT of RSV A neutralizing antibody at Day 31
oFlu D-QIV vaccine co-administered with RSV MAT compared to given alone based on Seroconversion rate (SCR) of Flu D-QIV HI antibody titers against 4 influenza strains at Day 31
•Evaluate the humoral immune response of:
oRSV MAT vaccine given alone and co-administered with Flu D-QIV in terms of RSV A, RSV B neutralizing antibody and RSV MAT IgG concentration at Days 1 and 31
oFlu D-QIV vaccine given alone and co-administered with RSV MAT vaccine in terms of antibody titers against 4 influenza strains at Days 1 and 31
•Evaluate seroprotection rate (SPR) and SCR of the Flu D-QIV vaccine given alone and co-administered with RSV MAT vaccine
•Evaluate the humoral immune response in 3 individual lots of RSV MAT

•Evaluar seguridad de RSVMAT administrado sola y junto con Flu D-QIV de la vacunación al final del estudio.
•Demostrar no inferioridad:
oRSV MAT + Flu D-QIV vs RSV MAT sola, según los GMT de Ac neutralizantes de VRS A (D31)
oRSV MAT + Flu D-QIV vs RSV MAT sola, según la tasa de seroconversión (SCR) de los títulos de Ac IH de las 4 cepas de gripe de Flu D-QIV (D 31)
•Evaluar la respuesta inmunitaria humoral:
oRSV MAT + Flu D-QIV & Flu D-QIV sola, a juzgar por los Ac neutralizantes del VRS A y B y la concentración de IgG anti-RSV MAT (D1 y D31)
oRSV MAT + Flu D-QIV & Flu D-QIV sola, a juzgar por los títulos Ac frente a las 4 cepas de gripe (D1 y D31)
•Evaluar tasa de seroprotección (SPR) y tasa SCR de la vacuna Flu D-QIV cuando se administra sola y se coadministra con la vacuna RSVMAT
•Evaluar la respuesta inmune humoral en 3 lotes individuales de RSVMAT

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
• Written or witnessed/thumb printed informed consent obtained from the participant prior to performance of any study specific procedure.
• Healthy female participants; as established by medical history and clinical examination, aged 18 to 49 years at the time of the first study intervention administration.
- Female participants of childbearing potential may be enrolled in the study, if the participant:
- has practiced adequate contraception for 1 month prior to study intervention administration, and
- has a negative pregnancy test on the day of study intervention administration, and
- has agreed to continue adequate contraception during the entire treatment period and for 1 month after completion of the study intervention administration.
• No local condition precluding injection in both left and right deltoid muscles.

•Participantes que, en opinión del investigador puedan y vayan a cumplir los requisitos del protocolo
•Consentimiento informado firmado o suscrito ante testigos/firmado con la huella digital de la participante antes de realizar ningún procedimiento específico.
•Mujeres sanas según lo establecido por la historia clínica y la exploración física, con una edad de entre 18 y 49 años en el momento de la primera administración de la intervención del estudio.
− Las mujeres participantes en edad fértil podrán inscribirse en el estudio, siempre que reúnan estas condiciones:
− Seguimiento de anticoncepción adecuada durante 1 mes antes de la administración de la vacuna del estudio
− Prueba negativa de embarazo en el día de la administración de la vacuna del estudio
− Conformidad para seguir con una anticoncepción adecuada durante todo el período de tratamiento y hasta 1 mes después de finalizar la intervención del estudio.
•Ningún trastorno local que impida la inyección en los músculos deltoides izquierdo y derecho.

E.4

Principal exclusion criteria

Medical conditions
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions;
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination;
• Current autoimmune disorder, for which the participant has received immune-modifying therapy within 6 months, before study vaccination;
• Hypersensitivity to latex;
• Acute or chronic clinically significant abnormality or poorly controlled pre-existent co-morbidities or any other clinical conditions, as determined by physical examination or medical history that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study;
• Significant or uncontrolled psychiatric illness;
• Recurrent history or uncontrolled neurological disorders or seizures;
• Documented HIV-positive participant;
• Body mass index> 40 kg/m^2;
• Any clinically significant* hematological parameter and/or biochemical laboratory abnormality.
*The investigator should use his/her clinical judgment to decide which abnormalities are clinically significant.
• Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.

Prior/Concomitant therapy
• Use of any investigational or non-registered product other than the study intervention(s) during the period starting 30 days before study intervention (Day -29 to Day 1), or planned use during the study period;
• Administration of long-acting immune-modifying drugs at any time during the study period;
• Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the study intervention or planned administration during the study period;
• Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first study intervention dose(s). For corticosteroids, this will mean prednisone 5 mg/day, or equivalent. Inhaled and topical steroids are allowed;
• Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after the vaccination dose;
• Administration of a seasonal influenza vaccine during the 6 months preceding entry into the study;
• Previous experimental vaccination against RSV.

Prior/Concurrent clinical study experience
Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product;

Other exclusions
• Pregnant or lactating female;
• Female planning to become pregnant or planning to discontinue contraceptive precautions;
• Alcoholism or substance use disorder within the past 24 months based on the presence of two or more of the following abuse criteria: hazardous use, social/interpersonal problems related to use, neglected major roles to use, withdrawal tolerance, use of larger amounts or longer, repeated attempts to quit or control use, much time spent using, physical or psychological problems related to use, activities given up to use, craving;
• Any study personnel or their immediate dependents, family, or household members.

Enfermedades
•Antecedentes de cualquier reacción o hipersensibilidad que pudieran exacerbarse por cualquier componente de las intervenciones del estudio
•Cualquier estado de inmunosupresión o inmunodeficiencia confirmada o sospechosa por la historia clínica y la exploración física
•Trastorno autoinmune actual, para el cual la participante haya recibido una terapia inmunomoduladora durante los 6 meses anteriores a la intervención del estudio
•Hipersensibilidad al látex
•Anomalía aguda o crónica con repercusión clínica o comorbilidad previa mal controlada o cualquier otra alteración clínica, detectada en la exploración física o recogida en la historia clínica que, en opinión del investigador, pueda suponer un riesgo adicional para la participante como consecuencia de su participación en el estudio
•Enfermedad psiquiátrica importante o no controlada
•Antecedentes de enfermedades neurológicas o de crisis convulsivas recidivantes o no controladas
•Participante con infección documentada por el VIH
•Índice de masa corporal> 40 kg/m^2
•Cualquier parámetro hematológico y/o anomalía bioquímica con repercusión clínica*.
*El investigador aplicará su juicio clínico para decidir qué anomalías poseen una repercusión clínica.
•Cualquier otro estado clínico que, en opinión del investigador, pudiera suponer un riesgo para la participante como consecuencia de su participación en el estudio.
Tratamiento previo/concomitante
•Uso de un producto en investigación o no registrado distinto de la(s) Intervención(es) del estudio desde 30 días antes de la intervención del estudio (día -29 a día 1) o uso previsto durante el período de estudio;
•Administración de inmunomoduladores de acción prolongada en cualquier momento durante el período de estudio
•Administración de inmunoglobulinas y/o cualquier producto sanguíneo o derivado del plasma durante los 3 meses anteriores a la intervención del estudio o administración prevista durante el periodo de estudio.
•Administración crónica de inmunosupresores o de otros medicamentos inmunomoduladores, a contar durante los 3 meses anteriores a la administración de la(s) primera(s) dosis de la intervención del estudio. En el caso de los corticoides, esto significa 5 mg/día de prednisona o equivalente. Se permite el uso inhalado y tópico de esteroides.
•Administración programada/administración de una vacuna no programada en el protocolo del estudio desde 30 días antes hasta 30 días después de administrar la dosis vacunal.
•Administración de una vacuna de la gripe estacional durante los 6 meses anteriores a la inclusión en el estudio.
•Administración previa de una vacuna experimental frente al VRS.
Experiencia previa y actual en ensayos clínicos
Participación simultánea en otro ensayo clínico, en el que la participante se haya expuesto o se puede exponer a una vacuna/producto en investigación o de naturaleza no experimental en cualquier momento del período de estudio.
Otras exclusiones
•Mujer embarazada o en período de lactancia.
•Mujer que desee quedarse embarazada o se disponga a interrumpir las medidas anticonceptivas.
•Alcoholismo o trastorno por uso de sustancias en los últimos 24 meses, basado en la presencia de dos o más de los siguientes criterios de abuso: uso peligroso, problemas sociales/interpersonales relacionados con el uso, descuido de roles importantes por el uso, tolerancia a la abstinencia, uso de cantidades mayores o durante más tiempo, tentativas repetidas para dejar o controlar el uso, duración prolongada del uso, problemas físicos o psicológicos relacionados con el uso, actividades abandonadas por el uso, ansia del uso
•Cualquier miembro del personal del estudio o sus colaboradores inmediatos, familiares o miembros de la unidad familiar

E.5 End points

E.5.1

Primary end point(s)

1. Percentage of participants reporting solicited administration site events in all study groups
2. Percentage of participants reporting solicited systemic events in all study groups
3. Percentage of participants reporting unsolicited adverse events (AEs) in all study groups
4. Percentage of participants reporting serious adverse events (SAEs) in all study groups
5. RSV MAT immunoglobulin G (IgG) concentrations for participants in RSV1, RSV2 and RSV3 groups at Day 31
6. Flu D-QIV haemagglutinin inhibition (HI) antibody titers against 4 influenza strains for participants in Flu+P group and RSV+Flu pooled group at Day 31.

1. Porcentaje de participantes que notifican acontecimientos solicitados en el lugar de inyección en todos los grupos de estudio
2. Porcentaje de participantes que notifican acontecimientos sistémicos solicitados en todos los grupos de estudio
3. Porcentaje de participantes que notifican acontecimientos adversos (AA) no solicitados en todos los grupos de estudio
4. Porcentaje de participantes que notifican acontecimientos adversos graves (AAG) en todos los grupos de estudio
5. Concentraciones de inmunoglobulina G (IgG) RSV MAT en los participantes de los grupos RSV1, RSV2 y RSV3 en el día 31
6. Títulos de anticuerpos en base a inhibidores de la hemaglutinina (IH) de 4 cepas de la gripe en el grupo de la vacuna gripe +placebo y en el grupo de RSV + gripe en el día 31.

E.5.1.1

Timepoint(s) of evaluation of this end point

1, 2. From Day 1 to Day 7 included
3, 4. From Day 1 to Day 30 included
5, 6. At Day 31

1, 2. Del día 1 al día 7 inclusive
3, 4. Del día 1 al día 30 inclusive
5, 6. El día 31

E.5.2

Secondary end point(s)

1. Percentage of participants reporting SAEs from first vaccination up to study end in all study groups
2. RSV A neutralizing antibody titers for participants in RSV+Flu pooled group and RSV pooled group at Day 1 and Day 31
3. Seroconversion rate (SCR) to Flu D-QIV HI antibody titers against 4 influenza strains for participants in Flu+P group and RSV+Flu pooled group at Day 31
4. RSV B neutralizing antibody titers for participants in RSV+Flu pooled group and RSV pooled group at Day 1 and Day 31
5. RSV MAT IgG concentrations for participants in RSV+Flu pooled group and RSV pooled group at Day 1 and Day 31
6. Flu D-QIV HI antibody titers against 4 influenza strains for participants in Flu+P group and RSV+Flu pooled group at Day 1 and Day 31
7. Seroprotection rate (SPR) to Flu D-QIV HI antibody titers for participants in Flu+P group and RSV+Flu pooled group at Day 1 and Day 31
8. RSV A neutralizing antibody titers for participants in RSV1, RSV2 and RSV 3 groups at Day 1 and Day 31
9. RSV B neutralizing antibody titers for participants in RSV1, RSV2 and RSV 3 groups at Day 1 and Day 31
10. RSV MAT IgG concentrations for participants in RSV1, RSV2 and RSV3 groups at Day 1 and Day 31.

1.Porcentaje de participantes que notifican AAG desde la primera vacunación hasta el final del estudio en todos los grupos de estudio
2.Títulos de anticuerpos neutralizantes del VRS A en el grupo de la vacuna VRS + gripe y del grupo de VRS en el día 1 y 31.
3.Tasa de seroconversión de los títulos de anticuerpos IH de las 4 cepas de Flu D-QIV* en el día 31 para los participantes del grupo de gripe + VRS y el grupo de la gripe +placebo
4.Títulos de anticuerpos neutralizantes del VRS B en el día 1 y en el día 31, en el grupo VRS + gripe y en el grupo VRS
5.Concentración de IgG VRS MAT en el día 1 y en el día 31 en el grupo VRS + gripe y en el grupo VRS
6.Títulos de anticuerpos IH de las 4 cepas de gripe de Flu D-QIV en el día 1 y el día 31 en el grupo de la VRS + gripe y en el grupo gripe + placebo
7.Tasa de seroprotección de los títulos de anticuerpos IH de las 4 cepas de gripe de Flu D-QIV HI en el día 1 y en el día 31 en el grupo gripe + VRS y en el grupo de gripe + placebo
8.Títulos de anticuerpos neutralizantes del VRS A en los días 1 y 31, en los grupos VRS1, VRS2 y VRS3.
9.Títulos de anticuerpos neutralizantes del VRS B en los días 1 y 31, en los grupos VRS1, VRS2 yVRS3.
10.Concentraciones de anticuerpos IgG frente a VRS en los días 1 y 31, en los grupos VRS1, VRS2 yVRS3.

E.5.2.1

Timepoint(s) of evaluation of this end point

1. From first vaccination up to study end (Day 1 to Day 181)
2, 4, 5, 6, 7, 8, 9, 10. At Day 1 and Day 31
3. At Day 31

1. Desde la primera vacunación hasta el final del studio (día 1 a día 181)
2, 4, 5, 6, 7, 8, 9, 10. El día 1 y 31
3. El día 31

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
Reactogenicity

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

Observer-blind study. Participants and study evaluators will be unaware of vaccine administered.

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

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

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

Canada

Korea, Republic of

United States

Finland

Spain

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

End of Study (EoS) must be achieved no later than 8 months after Last Subject Last Visit (LSLV).

La finalización del estudio tendrá lugar no más tarde de 8 meses tras la ultima visita del último paciente.

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

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:

1541

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

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

441

F.4.2

For a multinational trial

F.4.2.1

In the EEA

541

F.4.2.2

In the whole clinical trial

1541

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

Ninguno

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

2021-09-14

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-09-01

P. End of Trial
P.	End of Trial Status	Temporarily Halted

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Orphan Designation Number:
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