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    Summary
    EudraCT Number:2021-000357-26
    Sponsor's Protocol Code Number:214709
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-07-06
    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.1Member State ConcernedFinland - Fimea
    A.2EudraCT number2021-000357-26
    A.3Full title of the trial
    A Phase III, 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.
    A.3.1Title 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.
    A.3.2Name or abbreviated title of the trial where available
    RSV MAT-010
    A.4.1Sponsor's protocol code number214709
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGlaxoSmithKline Biologicals
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGlaxoSmithKline Biologicals
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Biologicals
    B.5.2Functional name of contact pointClinical Disclosure Advisor
    B.5.3 Address:
    B.5.3.1Street AddressRue de l’Institut, 89
    B.5.3.2Town/ cityRixensart
    B.5.3.3Post code1330
    B.5.3.4CountryBelgium
    B.5.4Telephone number442089904466
    B.5.6E-mailGSKClinicalSupportHD@gsk.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRSV MAT
    D.3.2Product code GSK3888550A
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    D.3.9.3Other descriptive nameGSKVx000000017076
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Influsplit Tetra/Fluarix Tetra
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline GmbH & Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Suspension for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    D.3.9.3Other descriptive nameInfluenza A virus, A/Victoria/2570/2019 (H1N1)pdm09 - like strain (A/Victoria/2570/2019, IVR-215), Inactivated
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    D.3.9.3Other descriptive nameInfluenza A virus, A/Cambodia/e0826360/2020 (H3N2) - like strain (A/Tasmania/503/2020, IVR-221), Inactivated
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    D.3.9.3Other descriptive nameB/Washington/02/2019 - like virus (B/Washington/02/2019, wild type)
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    D.3.9.3Other descriptive nameB/PHUKET/3073/2013-LIKE VIRUS (B/PHUKET/3073/2013, WILD TYPE)
    D.3.9.4EV Substance CodeSUB178474
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Healthy volunteers (prevention of RSV-associated lower respiratory tract illnesses (LRTIs))
    E.1.1.1Medical 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.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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 study end.
    • 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 3 influenza strains at Day 31 post administration.
    E.2.2Secondary objectives of the trial
    •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 3 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 3 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
    E.2.3Trial contains a sub-study No
    E.3Principal 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.
    E.4Principal 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.
    E.5 End points
    E.5.1Primary 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. Percentage of participants reporting SAEs in all study groups
    6. RSV MAT immunoglobulin G (IgG) concentrations for participants in RSV1, RSV2 and RSV3 groups at Day 31
    7. Flu D-QIV haemagglutinin inhibition (HI) antibody titers against 3 influenza strains for participants in Flu+P group and RSV+Flu pooled group at Day 31
    E.5.1.1Timepoint(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. From first vaccination up to study end (Day 1 to Day 181)
    6, 7. At Day 31
    E.5.2Secondary end point(s)
    1. RSV A neutralizing antibody titers for participants in RSV+Flu pooled group and RSV pooled group at Day 1 and Day 31
    2. Seroconversion rate (SCR) to Flu D-QIV HI antibody titers against 3 influenza strains for participants in Flu+P group and RSV+Flu pooled group at Day 31
    3. RSV B neutralizing antibody titers for participants in RSV+Flu pooled group and RSV pooled group at Day 1 and Day 31
    4. RSV MAT IgG concentrations for participants in RSV+Flu pooled group and RSV pooled group at Day 1 and Day 31
    5. Flu D-QIV HI antibody titers against 3 influenza strains for participants in Flu+P group and RSV+Flu pooled group at Day 1 and Day 31
    6. 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
    7. RSV A neutralizing antibody titers for participants in RSV1, RSV2 and RSV 3 groups at Day 1 and Day 31
    8. RSV B neutralizing antibody titers for participants in RSV1, RSV2 and RSV 3 groups at Day 1 and Day 31
    9. RSV MAT IgG concentrations for participants in RSV1, RSV2 and RSV3 groups at Day 1 and Day 31
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 3, 4, 5, 6, 7, 8, 9. At Day 1 and Day 31
    2. At Day 31
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    Reactogenicity
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Observer-blind (lot-to-lot consistency) & single-blind (immunogenicity, safety and reactogenicity)
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial7
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If 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.8.7Trial has a data monitoring committee No
    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).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days10
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1541
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 541
    F.4.2.2In 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
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-07-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-06-06
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