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    Summary
    EudraCT Number:2020-001355-40
    Sponsor's Protocol Code Number:212171
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-11-17
    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2020-001355-40
    A.3Full title of the trial
    A Phase III, randomized, double-blind, placebo-controlled multi-country study to demonstrate efficacy of a single dose of unadjuvanted RSV Maternal vaccine, administered IM to pregnant women 18 to 49 years of age, for prevention of RSV associated LRTIs in their infants up to 6 months of age
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase III double-blind study to assess safety and efficacy of an RSV Maternal unadjuvanted vaccine, in pregnant women and infants born to vaccinated mothers
    A.3.2Name or abbreviated title of the trial where available
    RSV MAT-009
    A.4.1Sponsor's protocol code number212171
    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.5.3.4CountryBelize
    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.3.9.3Other 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 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 placeboPowder and solvent for solution for injection
    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 lower respiratory tract illness)
    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 assess the efficacy of a single dose of the RSV Maternal vaccine administered to maternal participants in preventing medically assessed, RSV-associated severe (including very severe) OR any severity LRTIs in their infant participants up to 6 months of age
    E.2.2Secondary objectives of the trial
    -Efficacy of 1 dose of RSV MAT in preventing hospitalization, LRTI, and pneumonia in the infant participants and RSV associated Medically Attended RTIs (MA-RTIs) in all vaccinated maternal participants at specified timepoints
    -Effect of administering 1 dose of RSV MAT in maternal participants on time to first occurrence of severe (including very severe) & any severity medically assessed RSV-associated LRTIs in their infants
    -Immunogenicity of RSV MAT in a sub-cohort of maternal participants and their infants
    -Transfer of RSV-specific antibodies from a sub-cohort of maternal participants vaccinated with 1 dose of RSV MAT to their infants at the time of delivery
    -Reactogenicity of 1 dose of RSV MAT in a sub-cohort of maternal participants
    -Safety (Unsolicited AEs, Medically Attended AEs, SAEs, Pregnancy outcomes, pregnancy related AE of special Interest [AESIs]) in maternal participants
    -Safety (Neonatal AESIs, Medically Attended AEs, SAEs) in infants born from vaccinated mothers
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Maternal participants
    -Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
    -Participants who give written or witnessed/thumb printed informed consent after the study has been explained, and before any study specific procedures are performed, as per local regulations regulatory requirements.
    -Age 18 to 49 years, inclusive, at the time of study intervention.
    -Pre-pregnancy BMI 18.5 to 39.9 kg/m2, inclusive.
    -In good general maternal health as established by medical history and clinical examination before entering into the study.
    -Singleton pregnancy (including instances where the singleton pregnancy derives from a vanishing twin syndrome)..
    -At 24^0/7 to 34^0/7 weeks of gestation at the time of study vaccination (Visit 1), as established by:
    -last menstrual period (LMP) date corroborated by first or second trimester ultrasound examination (U/S) i.e. at or before 28 weeks of gestation.
    -1st or 2nd trimester U/S only, if LMP is unknown/uncertain
    -Certain LMP, corroborated by an U/S performed after 28 weeks of gestation is also acceptable.
    -No fetal genetic abnormalities (based on genetic testing, if performed).
    -No significant congenital malformations, as assessed by fetal anomaly ultrasound scan conducted at or beyond 18 weeks of gestation.
    -Willing to provide cord blood.
    -Who do not plan to give their child for adoption.
    -Who plan to reside in the study area for at least one year after delivery.
    -Willing to have the infant followed-up after delivery for a period of 12 months.

    Infant participants
    -Live-born from the study pregnancy.
    -If required per local regulations/guidelines, re-signed (confirmed) written or witnessed/thumb printed informed consent for study participation of the infant obtained from the infant’s mother and/or father and/or LAR, before performing any study specific procedure. OR, if permitted by local regulation, documented verbal consent for infant’s participation obtained from the parent’s/LAR at birth, followed by written consent obtained by (or before) Visit 2-newborn.
    E.4Principal exclusion criteria
    Maternal participants
    Medical conditions
    -History of allergic disease or reactions likely to be exacerbated by any component of the RSV vaccine
    -Hypersensitivity to latex
    -Significant complications in the current pregnancy:
    -Gestational hypertension unless blood pressure it is controlled and maintained in the normal range (<140mmHg and <90mmHg) through diet and/or antihypertensive medications
    -Gestational diabetes not controlled by medication, diet and/or exercise
    -Pre-eclampsia
    -Eclampsia
    -Intrauterine Growth Restriction/Fetal Growth Restriction
    -Placenta previa
    -Placental abruption, placenta accreta/percreta/increta, chorioamnionitis or any abnormalities that can impair the maternal-fetal circulation
    -Polyhydramnios
    -Oligohydramnios
    -Preterm labour or history of preterm labour in the current pregnancy
    -Any intervention to prevent preterm delivery or medical treatment for suspected preterm delivery, including administration of systemic corticosteroids for fetal lung maturation
    -Cholestasis
    -Other pregnancy-related complications (per investigator’s judgement)
    -Significant structural abnormalities of the uterus or cervix
    -History of 2 or more prior stillbirths or neonatal deaths/history of 2 or more preterm births at ≤34 weeks gestation/3 or more consecutive spontaneous abortions
    -Known HIV infection (as per serological tests performed during the current pregnancy)
    -Known or suspected HBV or HCV infection
    -Known or suspected infection during the current pregnancy with Toxoplasma, Parvovirus B19, Syphilis, Zika, Rubella, Varicella, CMV or primary genital Herpes Simplex
    -Active infection with tuberculosis
    -Known or suspected impairment of the immune system
    -Current autoimmune disorder for which the participant has received immune-modifying therapy within 6 months before study vaccination, or plans administration through delivery
    -Lymphoproliferative disorder or malignancy within 5 years before study vaccination
    -Acute or chronic clinically significant abnormality or poorly controlled pre-existent co-morbidities or any other clinical conditions that might pose additional risk to the participant due to participation in the study
    -Any conditions that may interfere with participant’s ability to comply with study procedures or receipt of prenatal care
    -Any condition which would increase the risks of study participation to the unborn infant
    Prior/Concomitant therapy
    -Prior receipt of an RSV vaccine in the current pregnancy
    -Use of any investigational/non-registered product other than the study vaccine/product as described below, or planned use during the period:
    -For a drug, vaccine or medical device: from 29 days before the dose of study vaccine
    -For immunoglobulins: 3 months before the dose of study vaccine/product
    The exception to this is investigational products administered in the setting of a pandemic which may be allowed following delivery
    -Planned administration/administration of any vaccine from 29 days before the dose of study vaccine or planned administration through delivery, except:
    -Seasonal influenza vaccines, tetanus vaccines, dTpa/Tdap – alone vaccines, dTpa/Tdap vaccines that also contain other antigens and Hepatitis B vaccines, all of which may be administered according to standard of care ≥15 days before or after study vaccination
    -Administration of immunoglobulins (except anti-Rh0D IG, which may be administered at any time), blood products or plasma derivatives within 3 months before study vaccination or planned administration through delivery
    -Administration of immune-modifying therapy within 6 months before the study vaccination, or planned administration through delivery. This includes but is not limited to:
    -Azathioprine, mycophenolate mofetil, 6-mercaptopurine, cyclosporine, tacrolimus, monoclonal or polyclonal antibodies
    -Prednisone ≥5 mg/day or equivalent for ≥14 days; Inhaled, intra-articular/intra-bursal and topical steroids are allowed
    -Corticosteroids administered for fetal lung maturation
    Prior/Concurrent clinical study experience
    -Concurrently participating in another clinical study, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product
    Other exclusions
    -Alcoholism or substance use disorder within the past 24 months based on DSM-5 criteria
    -A local condition that precludes injection of the study vaccine/product or precludes assessment of local reactogenicity
    -Consanguinity of maternal participant and her partner (second degree cousins or closer)
    -Any study personnel or their immediate dependants, family or household members
    Infant participants
    -Concurrently participating in another clinical study, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product
    -Any condition which would increase the risks of study participation to the infant
    -Child in care.
    E.5 End points
    E.5.1Primary end point(s)
    Number of infant participants with medically assessed, RSV-associated LRTIs, up to 6 months of age
    E.5.1.1Timepoint(s) of evaluation of this end point
    From birth to Day 181 post birth
    E.5.2Secondary end point(s)
    1. Number of infant participants with RSV-associated hospitalizations
    2. Number of infant participants with all-cause LRTIs
    3. Number of infant participants with all-cause LRTIs with hospitalization
    4. Number of infant participants with medically assessed, RSV-associated severe (including very severe) LRTIs, up to 7 months of age
    5. Number of infant participants with medically assessed, RSV-associated severe (including very severe) LRTIs, up to 8 months of age
    6. Number of infant participants with medically assessed, RSV-associated severe (including very severe) LRTIs, up to 9 months of age
    7. Number of infant participants with any medically assessed, RSV-associated LRTIs, up to 7 months of age
    8. Number of infant participants with any medically assessed, RSV-associated LRTIs, up to 8 months of age
    9. Number of infant participants with any medically assessed, RSV-associated LRTIs, up to 9 months of age
    10. Number of infant participants with medically assessed, RSV-associated LRTIs, up to 4 months of age
    11. Number of infant participants with medically assessed, RSV LRTIs
    12. Number of infant participants with all-cause pneumonia
    13. Time to first occurrence of severe (including very severe) and any medically assessed, RSV-associated LRTIs
    14. Number of maternal participants with RSV-associated medically attended RTIs (RSV-MA-RTIs)
    15. Humoral immune response in terms of RSV MAT immunoglobulin G (IgG) antibody Geometric Mean Concentration (GMCs) in maternal participants, at specified timepoints
    16. Humoral immune response in terms of RSV neutralizing antibody Geometric Mean Titers (GMTs) in maternal participants, at specified timepoints
    17. Humoral immune response in terms of RSV MAT IgG antibody GMCs in infant participants, at specified timepoints
    18. Humoral immune response in terms of RSV neutralizing antibody GMTs in infant participants, at specified timepoints
    19. Geometric mean ratio between cord blood and maternal RSV MAT IgG-specific antibody concentrations
    20. Number of maternal participants with solicited adverse events (AEs)
    21. Number of maternal participants with unsolicited adverse events (AEs)
    22. Number of maternal participants with at least one serious adverse event (SAE), AE leading to study termination or medically attended respiratory tract illness (MA-RTI)
    23. Number of maternal participants with at least one other medically attended AE
    24. Number of maternal participants with each pregnancy outcome
    25. Number of maternal participants with each pregnancy-related AE of special interest (AESI)
    26. Number of infant participants with each neonatal AESI
    27. Number of infant participants with at least one SAE, AE leading to study termination or medically Attended AEs (MAE), from birth up to 6 months after birth
    28. Number of infant participants with at least one SAE, AE leading to study termination or MAE, from birth up to 12 months after birth
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 2, 3 From birth to Day 181 post birth
    4, 7 From birth to Day 211 post birth
    5, 8 From birth to Day 241 post birth
    6, 9 From birth to Day 271 post birth
    10 From birth to Day 121 post birth
    11, 12, 13 From birth to Day 181 post birth
    14 From Day 1 (vaccination) to Day 181 post delivery
    15 Day 1 (pre vaccination), Day 31 and at delivery
    16 Day 1 (pre vaccination), Day 31 and at Delivery
    17, 18 At birth, Day 43 post birth, Day 121 post birth and Day 181 post birth
    19 At delivery or birth
    20 From Day 1 to Day 7
    21 From Day 1 to Day 30
    22 From Day 1 to Month 6 post delivery
    23. From Day 1 to Day 43 post delivery
    24, 25. From Day 1 to Day 43 post delivery
    26. From birth to Day 43 post birth
    27. From birth to Month 6 post birth
    28. From birth to Month 12 post birth
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    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
    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 Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned60
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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
    Argentina
    Australia
    Bangladesh
    Belgium
    Brazil
    Canada
    Colombia
    Finland
    France
    India
    Italy
    Korea, Republic of
    Mexico
    New Zealand
    Panama
    Philippines
    Russian Federation
    South Africa
    Spain
    Taiwan
    Thailand
    United Kingdom
    United States
    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) occurs with the last (infant) participant last visit
    (LSLV; Visit 5-NB).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    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: 10000
    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 No
    F.3.3.3Pregnant women Yes
    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 state2266
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2266
    F.4.2.2In the whole clinical trial 10000
    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 Decision2021-02-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-09-11
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