Clinical Trials

Clinical Trials

Vaccine clinical trials are studies conducted in people to find out if a vaccine under study is effective and safe.

Below are the tests we are or have been working on:

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  • Recruitment phase
  • Active testing
  • Historical

COVID-19

Title: Inmunogenicidad y seguridad de la vacuna de proteínas recombinantes de SARS-CoV-2 con adyuvante AS03 en adultos de 18 años en adelante como serie primaria, e inmunogenicidad y seguridad de una dosis de recuerdo de vacunas de proteínas recombinantes de SARS-CoV-2 con adyuvante (dos monovalentes y una bivalente)
Protocol code: VAT00002
Nº EudraCT: 2020-003370-41
Who it is aimed at: Adultos a partir de 18 años

Centre where it takes place: FISABIO-Oftalmología Médica (FOM)

 
 

I'm in!

Virus Respiratorio Sincitial

Title: 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.

Protocol code: 214709 (RSV MAT 010)
Nº EudraCT: 2021-000357-26
Who it is aimed at: Mujeres de 18-49 años de edad.

Centre where it takes place: FISABIO-Oftalmología Médica (FOM)

 
 

I'm in!

Gripe

Title: Estudio VIGIRAPhase IV, randomized, double-blind, controlled clinical trial of seasonal influenza vaccine in children aged 12-35 months to estimate efficacy against influenza and other respiratory infections.
EudraCT number: 2019-001186-33

To whom it is directed: Children of both sexes between 12 and 35 months of age (both inclusive) with recurrent colds

Centre where it takes place: CS Serrería I, CS Serrería II, CS de Nazaret, CS Trafalgar, CS L’Eliana, CS Ontinyent, CS Trinitat, Clínica Privada Gabriel Ruiz, CS Guillem De Castro, CS Torrent II, CS Puerto de Sagunto, y CS Burriana II (Castellón), CS Alboraia, CS Benicàssim, CS Fernando el Católico (Castellón), CS El Grao (Castellón), Hospital General Universitario de Castellón, Hospital Lluis Alcanyís (Xàtiva), CS Navarrés, CS Napoles i Sicilia.

See study

I'm in!

Meningococo

Title: Estudio de inmunogenia y seguridad de una vacuna conjugada antimeningocócica tetravalente con respecto a Nimenrix®, y cuando se administra sola o de manera concomitante con las vacunas 9vHPV y Tdap-IPV en adolescentes
sanos.
Protocol code: MEQ00071

Nº EudraCT: 2020-001665-37
Who it is aimed at: niños y niñas / adolescentes de 10 a 17 años de edad

Centre where it takes place: Serrería I, Serrería II, Burriana II, Nazaret, Malvarrosa y Puzol.

 
 

I'm in!

Title: Phase IIb, open-label clinical trial to assess the safety, tolerability, and immunogenicity of MenABCWY in healthy 2- and 6-month-old infants.
Protocol code: C3511002

Nº EudraCT: 2020-000948-60
Who it is aimed at: Children between 2 and 6 months.
Centre where it takes place: Serrería II, Eliana, Paiporta, Nazaret.
 
 

I'm in!

 

Neumococo:

Title: Ensayo en fase III, alaeatorizado, doble ciego para evaluar la seguridad de una vacuna antineumocócica 20-valente en lactantes sanos 
Protocol code: B7471013
EudraCT number: 2019-003307-35
Who it is aimed at: Breastfed children from 42 days to 98 days
Centers where it is done: Burriana II, Eliana, Malvarrosa, Paiporta y Serrería II.
 
 

Herpes Zóster:

Title: Efficacy, safety, and immunogenicity of GSK Biologicals' HZ/su vaccine GSK1437173A is a phase IIIb, open-label, long-term follow-up study (ZOE-LTFU) of studies 110390/113077 (ZOSTER-006/022) and evaluation of additional doses in older adults".
Protocol code: 201190 (ZOSTER-049) 
Promoter: GlaxoSmithKline, S.A.
Years: 2016-2023

See study

Title: Phase III, multicentre, randomized, blinded observer, placebo-controlled clinical trial to evaluate herpes zoster recurrence and the reactogenicity, safety, and immunogenicity of GSK Biologicals herpes zoster (HZ/su) vaccine when administered intramuscularly in a 0 and 2-month pattern to adults aged 50 years or older with a previous episode of herpes zoster.
Protocol code: 204939 (ZOSTER-062)
EudraCT number: 2016-000744-34
To whom it is directed: People over 50 years of age.
Centre where it takes place: FOM-Fisabio

See study

Virus Respiratorio Sincitial:

Title: Estudio de fase III, multinacional, observador ciego, aleatorizado, controlado con placebo para demostrar la eficacia de una dosis única de la vacuna en investigación RSVPreF3 OA de GSK en adultos de 60 años o más de edad.
Protocol code: 212494 (RSV OA=ADJ-006)
Nº EudraCT: 2020-000753-28
Who it is aimed at: Adultos de 60 años o más

Centre where it takes place: FISABIO-Oftalmología Médica (FOM)

See study

Title: Phase 3, multicentre, randomized, double-blind, controlled study with an active comparator drug to assess the safety, tolerability, and immunogenicity of V114 in healthy infants (PNEU-PED-EU- 1)
Protocol code: V114-025
To whom it is directed: Child of either sex between 12 and 17 months of age
Centre where it takes place: CS Malvarrosa, CS Serrería II, CS L’Eliana, CS Paiporta, and CS de Nazaret.

Title: Study to evaluate the safety, reactogenicity, and immunogenicity of GSK Biologicals' experimental respiratory syncytial virus (RSV) vaccine based on viral proteins encoded by a chimpanzee-derived adenovector (ChAd155 RSV) (GSK3389245A) in infants
Protocol code: 204894 (RSV-PED-011)
EudraCT number: 2018-000431-27
Center in which it is carried out: Nazaret, Paiporta, Malvarrosa

Title: Study to evaluate the safety, reactogenicity, and immunogenicity of GSK Biologicals' experimental respiratory syncytial virus (RSV) vaccine based on viral proteins encoded by a chimpanzee-derived adenovector (ChAd155 RSV) (GSK3389245A) in VRS-positive children.
Promoter: GlaxoSmithKline, S.A.
EudraCT number: 2016-000117-76
Years: 2016-2020

Title: Immunogenicity, reactogenicity, and safety study of different formulations of GSK Biologicals' ACWY conjugate meningitis vaccine (GSK3536820A and Menveo) administered to healthy adolescents and young adults aged 10 to 40 years.
Promoter: GlaxoSmithKline 207467 (MENACWY CONJ-069 [V59_78])
EudraCT number: 2017-003456-23
Years: 2018-2019

Title: Cross-vaccination study with the freeze-dried formulation of the Herpes Zoster subunit vaccine (HZ/su) from GSK Biologicals (GSK 1437173A) in subjects who previously received a placebo in the ZOSTER-006 and ZOSTER- 022 studies.
Protocol: 204486 (ZOSTER-056)
EudraCT number: 2015-000965-30
Promoter: GlaxoSmithKline, S.A.
Years: 2016-2018

Title: Phase IIIA, multicentre, randomized, blinded observer study to assess the consistency of three production batches of the liquid formulation of the rotavirus-attenuated human oral vaccine (NVR)
Protocol: 115461 (Rota-081)
EudraCT number: 2016-000598-19
Promoter: GlaxoSmithKline, S.A.
Years: 2017-2019

Title: Phase III multinational, observer-blind, randomized, controlled study with parallel-group, non-influenza vaccine comparators in children aged 6-35 months to evaluate the safety and efficacy of
Abbott's experimental quadrivalent flu vaccine".
Protocol: INFQ3003
EudraCT number: 2016-004904-74
Promoter: Abbott Biologicals B.V.
Years: 2017-2019

Title:  Phase 3, multicentre, randomized, double-blind, controlled study with an active comparator to assess the safety, tolerability, and immunogenicity of V114 followed by the administration, one year later, of PNEUMOVAX™23 in healthy adults aged 50 years and over (PNEU-PATH)
Protocol: V114 – 016
EudraCT number: 2017-004024-30
Promoter: Merck Sharp & Dohme
Years: 2018-2019

Title: Efficacy, safety, and immunogenicity study of GSK Biologicals Herpes Zoster vaccine GSK1437173A in adults 50 years and older.
Protocol: 110390. Zóster 006.
EudraCT Number: 2008-000367-42.
Promoter: GlaxoSmithKline
Years: 2010-2014

Title: Efficacy, safety, and immunogenicity study of GSK Biologicals Herpes Zoster vaccine GSK1437173A in adults 70 years and older.
Code: 113077. Zóster 022.
EudraCT number: 2009-015791-94.
Protocol: GlaxoSmithKline
Years: 2010-2014

Title: Phase IIIb, randomized, open-label study to assess the feasibility of priming with a single dose of group C meningococcal conjugate vaccine (NeisVac-C) in infants
Protocol: 670901
EudraCT number: 2010-019383-36
Promoter: Baxter Innovations GmbH
Years: 2010-2012

Title: Multi-centre, double-blind study of the safety, tolerability, and immunogenicity of a pneumococcal conjugate vaccine (V114) compared with Prevent 13™ in healthy infants.
Protocol: V114-003 EudraCT number: 2010-019775-29
Promoter: Merck Sharp & Dohme
Years: 2010-2012

Title: A randomized, double-blind, controlled phase III clinical trial using GARDASIL® (human papillomavirus [types 6, 11, 16, 18] vaccine (recombinant, adsorbed)) to study the immunogenicity and tolerability of V503 (9-valent human papillomavirus [HPV] L1 particle vaccine [VLP]) in pre-adolescent and adolescent girls (9-15 years of age).
Protocol: GDS01C

EudraCT number: 2010-023393-39
Promoter: Sanofi Pasteur MSD
Years: 2010-2012

Title: A randomized, placebo-controlled, single-blind phase 2 study to evaluate the safety, tolerability, and immunogenicity of the rLP2086 vaccine when administered in a 2- or 3-dose schedule to healthy older subjects ≥11 to ≤ 19 years
Protocol: B1971012. EudraCT number: 2009-014493-18
Promoter: Pfizer
Years: 2010-2012

Title: Open, multicentre, randomized and comparative study of the immunogenicity and safety of ZOSTAVAX®, when administered intramuscularly or subcutaneously to subjects >50 years of age
Protocol: ZTV03C
EudraCT number: 2009-012458-19
Promoter: Sanofi Pasteur MSD
Years: 2011-2012

Title: Phase III, blinded, randomized, multinational, controlled study with a non-influenza vaccine to demonstrate the efficacy of GSK Biologicals' quadrivalent seasonal influenza vaccine GSK2321138A (FLU D-QIV), administered intramuscularly in children 6-35 months of age
Protocol: 115345 (FLU D-QIV-004 PRI)
EudraCT number: 2011-000758-41
Promoter: GlaxoSmithKline
Years: 2011-2013

Title: Multi-centre, double-blind study of the safety, tolerability, and immunogenicity of a pneumococcal conjugate vaccine (V114) compared with a polysaccharide pneumococcal vaccine (PNEUMOVAX™23) and Prevent 13™ (13-valent pneumococcal conjugate vaccine [diphtheria protein CRM197]) in healthy adults aged 50 years or older.
Protocol: V114-002 EudraCT number: 2011-004542-18
Promoter: MSD
Year: 2012

Title: Phase 3, open-label, multi-center extension study to assess antibody persistence and response to a third or fifth dose of Novartis recombinant meningococcal B vaccine in 4-year-old children who previously participated in the V72P12E1 study.
Protocol: V72P12E2

EudraCT number: 2011-004931-30
Promoter: Novartis
Year: 2013

Title: Immunogenicity, safety and reactogenicity study of GSK Biologicals' quadrivalent seasonal influenza vaccine GSK2321138A administered to children who have previously participated in the 115345 study
Protocol: 116023 (FLU D-QIV-009 ext 004)
EudraCT number: 2012-001230-34
Promoter: GlaxoSmithKline
Years: 2012-2013

Title: Double-blind, randomized, controlled, multi-center study to assess the safety, tolerability, and immunogenicity of a new formulation of RotaTeq™
Protocol: V260-035

EudraCT number: 2012-001611-23
Promoter: Merck Sharp & Dohme
Years: 2013-2014

Title: Phase III, multicentre, randomized, blinded observer study to assess the safety of trivalent subunit influenza vaccines produced in mammalian cell culture (ccTV) or in embryonated eggs (ETV) in children and adolescents aged 3 to < 18 years at risk of influenza-related complications
Protocol: V58P15
EudraCT number: 2013-002080-26
Promoter: Novartis
Years: 2013-2014

Title: Phase III open study to evaluate the immunogenicity and safety of an alternating primary vaccination schedule (HEXA/PENTA/HEXA) including V419 (PR5I) at 2 and 6 months of age and PediacelR at 4 months of age
Protocol: PRI02C
EudraCT number: 2012-004221-25
Promoter: Sanofi Pasteur MSD
Years: 2013-2014

Title: Phase 3, masked observer, placebo-controlled, randomized trial to assess the safety, tolerability, and immunogenicity of the bivalent rLP2086 vaccine when administered in a 3-dose regimen to healthy young adults aged between ≥18 and < 26 years
Protocol: B1971016 (6108A1-2004).
EudraCT number: 2009-014492-46
Promoter: Pfizer
Years: 2013-2015

Title: Immunogenicity and safety study of GSK Biologicals' Priorix® vaccine (209762) with end-of-life potency compared to Merck & Co., Inc., administered according to a 2-dose pattern to healthy children in the 2nd year of life
Protocol: 115649 (MMR-161)
EudraCT number: 2011-004905-26
Promoter: GlaxoSmithKline
Years: 2013-2015

Title: Batch consistency study of GSK Biologicals' MMR vaccine (209762) (Priorix®) comparing immunogenicity and safety with Merck & Co. (M-M-R®II) in healthy children aged 12-15 months
Protocol: 115648 (MMR-160)
EudraCT number: 2011-004891-12
Promoter: GlaxoSmithKline
Years: 2013-2015

Title: Phase 3, randomized, placebo-controlled, active vaccine trial with the blinded observer to assess the safety, tolerability, and immunogenicity of a recombinant serogroup B meningococcal lipoprotein vaccine (rLP2086) administered to healthy subjects from ≥10 to < 26 years
Protocol: B1971014

EudraCT number: 2009-015198-11
Promoter: Pfizer
Years: 2013-2014

Title: Immunogenicity and safety study of a combined hexavalent DTaP-IPV-HB-Hib vaccine in a primary series of 3 doses in healthy infants in Europe.
Protocol: A3L39
EudraCT number: 2012-001055-39
Promoter: Sanofi Pasteur
Years: 2014-2015

Title: Phase III Clinical Trial to Study the Tolerability and Immunogenicity of a 2-dose regimen of V503, a Multi-Purpose L1 Particle Viroid (PV) Vaccine against Human Papillomavirus (HPV), administered to Pre-Adolescents and Adolescents (9-14 years) compared with Young Women (16-26 years).
Protocol: V503-010          EudraCT number: 2013-001314-15
Promoter: Merck Sharp &Dohme
Years: 2014- 2017

Title: Reminder and safety effect of a combined DTaPIPV- Hib vaccine, with or without Hep B vaccination, in healthy subjects 11-18 months of age who received a combined hexavalent or hexavalent/pentavalent vaccine during the primary series
Protocol: A3L40
Número EudraCT: 2012-001042-18
Promoter: Sanofi Pasteur
Years: 2014-2016

Title: Phase III, multicentre, randomized, blinded observer study (except in the trivalent influenza vaccine [TIV] groups, which will be open), placebo-controlled, conducted in healthy children aged 6-35 months
Protocol: GQM05
EudraCT number: 2013-001231-51
Promoter: Sanofi Pasteur
Years: 2014-2017

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The importance of clinical trials

Concern about vaccine safety has contributed to the development of appropriate methods for evaluating the potential benefits and risks of vaccines.

It is inconceivable to register a new medicine without clinical studies that evaluate its efficacy and the safety of its use.

Any new drug is thoroughly researched in the laboratory and tested on animals before approved for use in humans. However, it is clear that animal research, also called preclinical research, has significant limitations when applied to the study of human diseases.

Conducting studies with humans allows us to know the needs and effects of vaccines, specifically, in our bodies.

The importance of clinical trials is indisputable. Thanks to the people who test the candidate product, it is possible to determine if it is safe and effective to administer it to a part of the population. Without the participation of these people, many curable diseases today would continue to be lethal.

Frequently Asked Questions

They serve to determine or confirm the clinical, pharmacological, and pharmacodynamic effects. Clinical Trials detect adverse reactions and study the absorption, metabolism, and elimination of investigational drugs to determine their safety and efficacy in humans.

Once you decide to participate in the Trial, you will be thoroughly informed of all the benefits and risks involved in participating. You will also be required to sign an informed consent form attesting that you have been properly informed of all matters pertaining to the trial and you will be given a copy of this document for your reference at any time.

Advantages

  • You can get a new vaccine or treatment that works that is impossible to obtain outside of a clinical trial.
  • Regular monitoring of your health
  • It can help you and others.

Risks

  • Possibility of previously unknown side effects (there is insurance to compensate in case something serious happens to you).

All of your doctor's records are confidential. Only your doctor and the team that treats you can see them.

In the trial, none of the medical data collected about you will have your name on it.

For safety reasons, the trial team will write to your family doctor about the treatment you are receiving.

In Spain, the legislation only allows for small compensation payments for inconveniences and travel. The amount of compensation will be related to the trial but will never be so high as to induce a subject to participate for financial reasons.

YES. The treatments have been extensively tested in laboratory trials before they are tested on groups of patients.

Each curriculum (protocol) is inspected and must be approved by an ethics committee to guarantee its safety and good practice for the participants.

Trial reports cannot contain any patient names, or other identifying details, all of which are confidential. Even so, medical researchers must publish the results obtained from clinical trials. These will be published in a medical journal, where all the data obtained from all the people who took part will be reported on how well the treatment worked, as well as any adverse effects. 

If you wish to know the result of the trial, the researchers can inform you about the media in which it has been published.

You may withdraw from a trial at any time. You do not have to give a reason for doing so, and it will in no way harm your usual medical treatment.

Any person of any age who meets the specific criteria of the study can partake in the trial. (age, proximity to the center of the study, etc.)