Clinical Trials Register

Summary
EudraCT Number:	2011-003243-21
Sponsor's Protocol Code Number:	TRANSGRIPE 1-2
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2011-08-09
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2011-003243-21

A.3

Full title of the trial

Randomized, comparative and prospective clinical trial evaluating efficacy and safety of a dose of seasonal flu vaccine compared to two doses of vaccine for prevention of influenza in solid organ transplant recipients

Ensayo clínico prospectivo aleatorizado comparativo de la eficacia y seguridad de una dosis de vacuna estacional respecto a dos dosis de vacunas como prevención de la gripe en receptores de trasplante de órgano sólido

A.3.1

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

clinical trial to evaluating efficacy of a double dose of seasonal flu vaccine compared to single dose for prevention of influenza in solid organ transplant recipients

Estudio para evaluar la eficacia y seguridad de dos dosis de vacuna para la gripe estacional con respecto a una sola dosis, en pacientes que reciben transplante de órgano sólido

A.4.1

Sponsor's protocol code number

TRANSGRIPE 1-2

A.5.4

Other Identifiers

Name:

Number:

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	Fundación Pública Andaluza Progreso y Salud
B.1.3.4	Country	Spain
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	Ministerio de Sanidad y Política Social
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Fundación Pública Andaluza Progreso y Salud
B.5.2	Functional name of contact point	representante
B.5.3	Address:
B.5.3.1	Street Address	Avda. Américo Vespucio, 5-2; 2ª planta
B.5.3.2	Town/ city	Seville
B.5.3.3	Post code	41092
B.5.3.4	Country	Spain
B.5.4	Telephone number	34955040450
B.5.5	Fax number	34955040457
B.5.6	E-mail	gestionensayosclinicos.fps@juntadeandalucia.es

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	GRIPAVAC
D.2.1.1.2	Name of the Marketing Authorisation holder	SANOFI PASTEUR MSD, S.A.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	GRIPAVAC
D.3.2	Product code	NA
D.3.4	Pharmaceutical form	Solution 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 Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	NYMC X-179A
D.3.9.3	Other descriptive name	A/CALIFORNIA/7/2009 (H1N1)
D.3.9.4	EV Substance Code	SUB30763
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	15 to NA
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	NYMC X-187
D.3.9.3	Other descriptive name	A/PERTH/16/2009 (H3N2) - LIKE STRAIN (A/VICTORIA/210/2009 REASS. NIB-65)
D.3.9.4	EV Substance Code	SUB31352
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	15 to NA
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	B/BRISBANE/60/2008-LIKE VIRUS
D.3.9.4	EV Substance Code	SUB30542
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	15 to NA
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

seasonal influenza prophylaxis in trasplant receipiens

profilaxis de la gripe estacional en pacientes receptores de órganos sólidos

E.1.1.1

Medical condition in easily understood language

to determine whether two doses of flu vaccine in trasplant receipiens is better than one single dose.

E.1.1.2

Therapeutic area

Body processes [G] - Immune system processes [G12]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.0
E.1.2	Level	LLT
E.1.2	Classification code	10021829
E.1.2	Term	Infection in solid organ transplant recipients
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

to study whether two doses of flu vaccine work better than single dose in transplant recipiens

E.2.2

Secondary objectives of the trial

1. To assess the humoral immune response to one and two doses of seasonal flu vaccine through the levels of neutralizing antibodies in serum.
2. To determine the specific cellular immune response caused after one and two doses of seasonal flu vaccine through the stimulation of cells in memory vito specific influenza virus A and B.
3. To evaluate the clinical efficacy of seasonal flu vaccine in the recipient of solid organ transplantation.
4. To assess the humoral and cellular immunity in the long term (one year) of the seasonal flu vaccine.
5. To establish the effectiveness of one and two doses of seasonal flu vaccine in groups with lower response to the vaccine. (Liver failure, use of mTOR inhibitors, first 6 months after transplantation).
6. To determine the safety of two doses of seasonal flu vaccine.

1. Evaluar la respuesta inmune humoral a una y dos dosis de vacuna de la gripe estacional a través de los niveles de anticuerpos neutralizantes en suero.
2. Determinar la respuesta inmune celular específica originada tras una y dos dosis de vacuna de la gripe estacional a través de la estimulación in vito de células de memoria específicas de los virus de la gripe A y B.
3. Evaluar la eficacia clínica de la vacuna de la gripe estacional en el receptor de trasplante de órgano sólido.
4. Evaluar la inmunidad celular y humoral a largo plazo (un año) de la vacuna de la gripe estacional.
5. Establecer la efectividad de una y dos dosis de vacuna de la gripe estacional en grupos con menor respuesta a la vacuna. (insuficiencia hepática, uso de inhibidores de mTOR, primeros 6 meses tras el trasplante).
6. Determinar la seguridad de dos dosis de vacuna de gripe estacional.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. solid organ transplant receipation.
2. 16 years or older.
3. More than 30 days after transplantation.
4. Negative pregnancy test for women of childbearing age
5. The patient must give informed consent

El paciente debe cumplir todos los criterios siguientes:

1. Receptor de trasplante de órgano sólido.
2. Edad mayor o igual a 16 años.
3. Más de 30 días postrasplante.
4. Test de gestación negativo en caso de mujeres en edad fértil
5. El paciente debe otorgar su consentimiento por escrito

E.4

Principal exclusion criteria

1. No written informed consent.
2. Acute rejection within 15 days prior to vaccination.
3. Pregnancy.
4. Hypersensitivity to the active substance, any of the excipients and waste, for example: eggs, egg albumin, chicken proteins.
5. History of a previous serious reaction to immunization (eg Guillain-Barré syndrome).

1. Ausencia de consentimiento escrito previa información del estudio al paciente (anexo1).
2. Rechazo agudo en los 15 días previos a la vacunación.
3. Embarazo.
4. Hipersensibilidad a los principios activos, a cualquiera de los excipientes y a los residuos, por ejemplo: huevos, a la ovoalbúmina, proteínas de pollo.
5. Antecedentes de una reacción a vacunación previa grave (por ejemplo síndrome de Guillain-Barré).

E.5 End points

E.5.1

Primary end point(s)

Difference in seroconversion rates in both groups

Diferencia de las tasas de seroconversión en ambos grupos

E.5.1.1

Timepoint(s) of evaluation of this end point

at 5 and 10 weeks of the first vaccine dose

A las 5 y a las 10 semanas de la primera dosis de vacunación

E.5.2

Secondary end point(s)

1. Geometric average postvaccination antibody titers and rate of increase between pre-and post-vaccination geometric mean, post-vaccination seroprotection rate (or percentage of individuals with a titer ? 1 / 40 as measured by RIH).
2. Occurrence of grade 3 or 4 toxicity, death, hospitalization, retransplantation, acute rejection and chronic rejection.
3. Detection of clinical cases of influenza following immunization. Nasal swabs to confirm infection with influenza virus by RT-PCR. Clinical severity (hospitalization, ICU admission, death, rejection). Time to clinical stability.

1. Media geométrica de los títulos de anticuerpos postvacunal y razón de incremento entre media geométricas pre y postvacunales, tasa de seroprotección postvacunal (o porcentaje de individuos con un título de anticuerpos ?1/40 medido por RIH).
2. Aparición de toxicidad grados 3 ó 4, muerte, hospitalización, retrasplante, rechazo agudo y rechazo crónico.
3. Detección de casos clínicos de gripe postvacunal. Frotis nasal para la confirmación de la infección por el virus de la gripe mediante RT-PCR. Gravedad del cuadro clínico (hospitalización, ingreso en UCI, muerte, rechazo). Tiempo hasta la estabilidad clínica.

E.5.2.1

Timepoint(s) of evaluation of this end point

At selection time, 5 weeks, 10 weeks and 1 year.

Selección, 5 semanas, 10 semanas y 1 año.

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

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)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

una sola dosis

one dose

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the 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

Duración del tratamiento: a las 5 y 10 semanas (solo brazo B) desde el inicio, seguimiento hasta UN año después de la visita de screening.

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:

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:

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

400

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

Yes

F.3.3.7.1

Details of other specific vulnerable populations

organ trasplanted

F.4 Planned number of subjects to be included

F.4.1

In the member state

462

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

2011-10-17

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-10-03

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2016-07-28

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials