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    Summary
    EudraCT Number:2024-000563-20
    Sponsor's Protocol Code Number:223247
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2025-07-30
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2024-000563-20
    A.3Full title of the trial
    A Phase 2a, open label, randomized, interventional study to assess the safety and immunogenicity of alternative vaccination regimens and reduced antigen doses of RTS,S/AS01E vaccine in healthy children aged 5-60 months in a malaria-endemic area
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess the safety and immunogenicity of a vaccine against malaria in healthy children aged 5-60 months.
    A.3.2Name or abbreviated title of the trial where available
    Malaria-GVGH 001 (H10_01TP)
    A.4.1Sponsor's protocol code number223247
    A.5.4Other Identifiers
    Name:PACTRNumber:PACTR202503849420187
    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 pointGlaxoSmithKline Biologicals
    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 Yes
    D.2.1.1.1Trade name Mosquirix
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline Biologicals
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameRTS,S/AS01E
    D.3.4Pharmaceutical form Powder and suspension for suspension for injection
    D.3.4.1Specific paediatric formulation Yes
    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 INNPlasmodium falciparum and hepatitis B vaccine
    D.3.9.3Other descriptive nameRTS,S [portion of P. Falciparum circumsporozoite protein fused with hepatitis b surface antigen (RTS), and combined with hepatitis B surface antigen (S)]
    D.3.9.4EV Substance CodeSUB167247
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number5 to 25
    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.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prophylaxis for Malaria caused by Plasmodium falciparum and hepatatis B
    E.1.1.1Medical condition in easily understood language
    Malaria and hepatitis B
    E.1.1.2Therapeutic area Diseases [C] - Parasitic Diseases [C03]
    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 immunogenicity profile of RTS,S/AS01E when administered in different doses and schedules, after 12 months post Dose 3 administration.
    E.2.2Secondary objectives of the trial
    1) To describe the immunogenicity profile of RTS,S/AS01E when administered in different doses and schedules, after each study vaccine
    administration.
    2) To assess the safety and reactogenicity profile of RTS,S/AS01E for each schedule in terms of SAEs, unsolicited AEs, and AESIs.
    3) To describe the antibody response to the anti-HBs for each schedule.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Healthy male or female participants aged 5 to 60 months at the time of the first vaccination, who have previously completed the WHO Expanded Programme on Immunization (EPI) vaccinations or for younger infants have received all required vaccinations at point of recruitment according to the schedule for the country where the study is conducted.
    2. Participants’ parent(s)/Legally Acceptable Representative(s) (LAR), in the opinion of the investigator, can and will comply with the requirements of the protocol (eg, completion of the diaries, returning for follow-up visits).
    3. Written or witnessed/thumb-printed informed consent obtained from the participant’s parent(s)/LAR prior to performance of any study-specific procedure.
    4. Healthy, as established by medical history and clinical examination
    5. Negative for human immunodeficiency virus (HIV), HBV, and hepatitis C virus (HCV)
    6. With hemoglobin levels >8 g/dL.
    7. Born after a gestation period of ≥37 weeks
    E.4Principal exclusion criteria
    1. Progressive, unstable, or uncontrolled clinical conditions
    2. History (known or suspected) of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine.
    3. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
    4. Clinical conditions representing a contraindication to IM vaccination or blood draws.
    5. Any behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the participant’s ability to participate in the study.
    6. Recurrent history of or uncontrolled neurological disorders or seizures.
    7. Undernutrition, defined as WHO Z-score less than –2 standard deviation.
    8. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant as a result of participation in the study, for example, any major congenital defects.
    9. Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination and medical history.
    10. Administration of long-acting immune-modifying drugs (eg, infliximab) during the study period starting 3 months before the first dose of study vaccine or planned administration during the study period.
    11. Prior receipt of a malaria vaccine (registered or experimental).
    12. Use of any investigational or non-registered product (drug, vaccine, or medical device)*other than the study vaccine during the period starting 30 days before the first dose of study vaccine (Day –30 to Day 1), or planned use during the study period.
    *Use of herbs and traditional treatments is not considered an exclusion criterion.
    13. Planned administration of a vaccine not foreseen by the study protocol or the country EPI in the period starting 14 days before each dose and ending 28 days after the last dose of study vaccine administration*, with the exception of flu vaccines and vaccines administered as part of a public health vaccination campaign*.
    *If emergency mass vaccination for an unforeseen public health threat (eg, a pandemic) is organized by public health authorities outside the routine immunization program, the time period described above can be reduced, provided the vaccination is used according to the local governmental recommendations and the Sponsor is notified.
    Under such circumstances, a participant may be considered eligible for study enrollment and/or study vaccine administration after the appropriate window for delay has passed, if the participant is confirmed to be eligible after inclusion/exclusion criteria have been re checked.
    14. Administration of immunoglobulins and/or any blood products or plasma derivatives, or bone marrow transplantation, during the period starting 3 months before the first dose of study vaccine or planned administration during the study period.
    15. Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first vaccine dose or planned administration during the study period. For corticosteroids, this means prednisone ≥0.5 mg/kg/day or 20 mg/day, whichever is the maximum dose for pediatric participants. Inhaled and topical steroids are allowed.
    16. 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 intervention (drug or invasive medical device).
    17. Any study personnel’s immediate dependents, family, or household members.
    18. Child in care.
    E.5 End points
    E.5.1Primary end point(s)
    Total IgG levels against NANP repeats region of CS protein measured as determined using multiplex immunoassay.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at 12 months post Dose 3,
    E.5.2Secondary end point(s)
    1) Total IgG levels against NANP repeats region of CS protein measured in all study groups as determined using multiplex immunoassay.
    2) a. The occurrence of all solicited events within 7 days after each study vaccine
    b. The occurrence of all SAEs from first study vaccine administration to the end of the study.
    c. The occurrence of all SAEs from first study vaccine administration to 12 months after the last study vaccine administration.
    d. Occurrence of AEs/SAEs leading to withdrawal from the study and/or discontinuation of study vaccine, from first study vaccine administration to the end of the study.
    e. The occurrence of unsolicited AEs within 30 days after each study vaccine administration.
    f. The occurrence of AESIs (febrile convulsions) within 7 days after each dose of study vaccine.
    3) a. Anti-HBs antibody (IgG) concentrations measured in all study groups as determined using multiplex immunoassay.
    b. Participants achieving anti-HBs IgG levels above 6.2 IU/L and 10.0 IU/L in all study groups.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) at Month 0, 1, 2, 3, 7, 8, 14, and 19
    2) a. on the day of the study vaccine administration and the 6 subsequent days
    b. from Day 1 to Day 571
    c. from Day 1 to 12 months after the last study vaccine administration.
    d. from Day 1 to Day 571
    e. on the day of study vaccine administration and the 29 subsequent days
    f. on the day of vaccination and 6 subsequent days
    3) a. at Month 0, 1, 2, 3, 7, 8, 14, and 19
    b. at Month 0, 1, 2, 3, 7, 8, 14, and 19
    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 No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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
    assess the safety and immunogenicity of alternative vaccination regimens and reduced antigen doses of RTS,S/AS01E vaccine
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    RTS,S drug substance diluted at 12.5 and 5 mcg/mL with adjuvant
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Rwanda
    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 is defined as the date of the last subject last visit (LSLV) or date of last testing of the Human Biological Sample data result (related to primary and secondary endpoints) released, whichever comes last.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 238
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 105
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 133
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    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 No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    children aged 5-60 months
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 238
    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
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Center for Family Health Research
    G.4.3.4Network Country Rwanda
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Rinda Ubuzima/ Gatenga Medicalized Health Center/ University of Rwanda
    G.4.3.4Network Country Rwanda
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Rwanda
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