Summary
EudraCT Number:2021-005178-25
Sponsor's Protocol Code Number:216152
National Competent Authority:Belgium - FPS Health-DGM
Clinical Trial Type:EEA CTA
Trial Status:Ongoing
Date on which this record was first entered in the EudraCT database:2022-07-13
Trial results
A. Protocol Information
A.1Member State ConcernedBelgium - FPS Health-DGM
A.2EudraCT number2021-005178-25
A.3Full title of the trial
A Phase 1/2a, observer-blind, randomized, controlled, two-stage, multi-country study to evaluate the safety, reactogenicity, and immune response of the trivalent vaccine against invasive nontyphoidal Salmonella (iNTS) and Typhoid Fever in healthy European and African adults
A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
A study to evaluate safety, reactogenicity, and immune response of GVGH iNTS TCV vaccine against invasive nontyphoidal Salmonella and Typhoid Fever
A.3.2Name or abbreviated title of the trial where available
INTS-GMMA GVGH-002
A.4.1Sponsor's protocol code number216152
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 SA
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 SA
B.4.2CountryBelgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisationGlaxoSmithKline Biologicals SA
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-mail[email protected]
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 nameiNTS-TCV vaccine
D.3.2Product code GSK4077164A
D.3.4Pharmaceutical form Suspension 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 INNNot Applicable
D.3.9.2Current sponsor code2363-GMMA
D.3.9.3Other descriptive nameSalmonella Typhimurium 2363-GMMA
D.3.9.4EV Substance CodeSUB222636
D.3.10 Strength
D.3.10.1Concentration unit µg microgram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNNot Applicable
D.3.9.2Current sponsor code2157-GMMA
D.3.9.3Other descriptive nameSalmonella Enteritidis 2157-GMMA
D.3.9.4EV Substance CodeSUB222635
D.3.10 Strength
D.3.10.1Concentration unit µg microgram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNNot Applicable
D.3.9.2Current sponsor codeGSKVx000000030788
D.3.9.3Other descriptive nameTyphoid Vi polysaccharide (from Citrobacter freundii sensu lato) conjugated to CRM197
D.3.9.4EV Substance CodeSUB283502
D.3.10 Strength
D.3.10.1Concentration unit µg microgram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number25
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.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 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 nameiNTS GMMA vaccine
D.3.2Product code GSK4077164A
D.3.4Pharmaceutical form Suspension 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 INNNot Applicable
D.3.9.2Current sponsor code2363-GMMA
D.3.9.3Other descriptive nameSalmonella Typhimurium 2363-GMMA
D.3.9.4EV Substance CodeSUB222636
D.3.10 Strength
D.3.10.1Concentration unit µg microgram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number20
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.IMP: 3
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 nameiNTS GMMA vaccine
D.3.2Product code GSK4077164A
D.3.4Pharmaceutical form Suspension 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 INNNot Applicable
D.3.9.2Current sponsor code2157-GMMA
D.3.9.3Other descriptive nameSalmonella Enteritidis 2157-GMMA
D.3.9.4EV Substance CodeSUB222635
D.3.10 Strength
D.3.10.1Concentration unit µg microgram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number20
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.IMP: 4
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 nameTyphoid Vi Conjugate Vaccine (Monovalent)
D.3.4Pharmaceutical form 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 INNNot Applicable
D.3.9.2Current sponsor codeGSKVx000000030788
D.3.9.3Other descriptive nameTyphoid Vi polysaccharide (from Citrobacter freundii sensu lato) conjugated to CRM197
D.3.9.4EV Substance CodeSUB283502
D.3.10 Strength
D.3.10.1Concentration unit µg microgram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number25
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 placeboSuspension for injection
D.8.4Route of administration of the placeboIntramuscular use
D.8 Placebo: 2
D.8.1Is a Placebo used in this Trial?Yes
D.8.3Pharmaceutical form of the placeboSolution 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 invasive nontyphoidal Salmonella disease and typhoid fever)
E.1.1.1Medical condition in easily understood language
Infection caused by Salmonella typhimurium (S. typhimurium), Salmonella enteritidis (S. enteritidis), and/or Salmonella typhi (S. typhi)
E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
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 profile of GSK Vaccines Institute for Global Health (GVGH) invasive nontyphoidal Salmonella-typhoid conjugate vaccine (iNTS-TCV) vaccine in healthy European/African adults
E.2.2Secondary objectives of the trial
• To evaluate the long term safety profile of GVGH iNTS-TCV vaccine in healthy European/African adults
• To evaluate the immunogenicity profile of GVGH iNTS-TCV vaccine in healthy European adults
• To evaluate seroresponse with the GVGH iNTS-TCV vaccine after each study intervention administration in healthy European adults
• To evaluate the immunogenicity profile of GVGH iNTS-TCV vaccine in healthy African adults
• To evaluate seroresponse with the GVGH iNTS-TCV vaccine after each study intervention administration in healthy African adults
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 participants as established by medical history, clinical examination, and laboratory assessment.
- Participant satisfying screening requirements.
- A male or female between and including 18 and 50 years of age at the time of the first study intervention administration.
- Female participants of nonchildbearing potential may be enrolled in the study. Nonchildbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy, or post-menopause.
- Female participants of childbearing potential may be enrolled in the trial if the participant:
o Has practiced adequate contraception for 1 month prior to study intervention administration, and
o Has a negative pregnancy test on the day of study intervention administration, and
o Has agreed to continue adequate contraception during the entire treatment period and for 1 month after completion of the study intervention administration series.
- Blood sample for simultaneous follicle-stimulating hormone (FSH) and estradiol levels may be collected at the discretion of the Investigator to confirm non-reproductive potential according to local laboratory reference range.
- Genetic testing for HLA-B27 will be performed at Screening and only participants with a negative result will be allowed to participate in the study*.
*Only for Stage 1.
- For Malawi (Stage 2), the participant lives in Blantyre and has agreed to remain in Blantyre for the study duration.
E.4Principal exclusion criteria
Medical Conditions
- Known exposure to S. Typhi and nontyphoidal Salmonella confirmed by blood culture during the period starting 3 years prior to first study intervention administration confirmed using past medical history.
- History of any reaction or hypersensitivity associated with any component of the study interventions.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Recurrent history or uncontrolled neurological disorders or seizures.
- Any clinically significant* hematological and/or biochemical laboratory abnormality.
* The Investigator should use his/her clinical judgment to decide which abnormalities are clinically significant from the panel of tests in the list of safety assays.
- Clinical conditions representing a contraindication to IM injections and/or blood draws.
- 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.
- Confirmed positive COVID-19 polymerase chain reaction or lateral flow test during the period starting 28 days before the first administration of study vaccines (Day −28 to Day 1).
- Acute or chronic illness which may be severe enough to preclude participation.
- Any other clinical condition that, in the opinion of the Investigator, might pose additional risk to the participant due to participation in the study.
- All medical conditions will be assessed by the Investigator who may use his/her discretion to decide if the participant meets the exclusion criteria.
Prior/Concomitant Therapy
- History of receiving any typhoid vaccine (Ty21a, Vi capsular polysaccharide, or TCV) in the participant’s life.
- History of receiving any investigational iNTS or GMMA vaccines in the participant’s life.
- Use of any investigational or non-registered product other than the study interventions during the period beginning 30 days (Days −30 to 1) before the first dose of study interventions, or their planned use during the study period.
- A vaccine not foreseen by the study protocol administered during the period starting at 14 days before the first dose and ending 28 days after the last dose of study interventions administration*, with the exception of flu vaccines or COVID-19 vaccine.
*In case emergency mass vaccination for an unforeseen public health threat (eg, a pandemic) is recommended and/or organized by public health authorities outside the routine immunization program, the time period described above can be reduced if necessary for that vaccine, provided it is used according to the local governmental recommendations and that the Sponsor is notified accordingly.
When regulations allow, the recommended time intervals for administration of these vaccines are at least 7 days before or 7 days after (at least 14 days before or 14 days after in case of live vaccines) each dose of study intervention administration.
- Administration of long-acting immune-modifying drugs at any time during the study period (eg, infliximab).
- Administration of Ig and/or any blood products or plasma derivatives during the period starting 3 months before the administration of the first dose of study interventions or planned administration during the study period.
- 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 study intervention dose(s). For corticosteroids, this will mean prednisone equivalent ≥20 mg/day for adult participants. Inhaled and topical steroids are allowed.
Prior/Concurrent Clinical Study Experience
- Concurrently participating in another clinical trial, 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 (vaccine and drug).
Other Exclusions
- Pregnant or lactating female
- Female planning to become pregnant or planning to discontinue contraceptive precautions
-History of/current chronic alcohol consumption and/or drug abuse. This will be decided at the discretion of the Investigator. Chronic alcohol consumption is defined as one or more of the following:
o A prolonged period of frequent and heavy alcohol use
o The inability to control drinking once it has begun
o Physical dependence manifested by withdrawal symptoms when the individual stops using alcohol
o Tolerance or the need to use increasing amounts of alcohol to achieve the same effects
o A variety of social and/or legal problems arising from alcohol use.
- Any study personnel or their immediate dependents, family, or household members.
E.5 End points
E.5.1Primary end point(s)
1. Number of participants in Europe/Stage 1 with solicited administration site events after the first study intervention administration
2. Number of participants in Europe/Stage 1 with solicited administration site events after the second study intervention administration
3. Number of participants in Europe/Stage 1 with solicited administration site events after the third study intervention administration
4. Number of participants in Europe/Stage 1 with solicited systemic events after the first study intervention administration
5. Number of participants in Europe/Stage 1 with solicited systemic events after the second study intervention administration
6. Number of participants in Europe/Stage 1 with solicited systemic events after the third study intervention administration
7. Number of participants in Europe/Stage 1 with unsolicited adverse events (AEs) after the first study intervention administration
8. Number of participants in Europe/Stage 1 with unsolicited AEs after the second study intervention administration
9. Number of participants in Europe/Stage 1 with unsolicited AEs after the third study intervention administration
10. Number of participants in Europe/Stage 1 with serious adverse events (SAE)
11. Number of participants in Europe/Stage 1 with AEs/SAEs leading to withdrawal from the study and/or withholding doses of study intervention
12. Number of participants in Europe/Stage 1 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 8
13. Number of participants in Europe/Stage 1 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 64
14. Number of participants in Europe/Stage 1 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 176
15. Number of participants in Europe/Stage 1 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 29
16. Number of participants in Europe/Stage 1 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 85
17. Number of participants in Europe/Stage 1 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 197
18. Number of participants in Africa/Stage 2 with solicited administration site events after the first study intervention administration
19. Number of participants in Africa/Stage 2 with solicited administration site events after the second study intervention administration
20. Number of participants in Africa/Stage 2 with solicited administration site events after the third study intervention administration
21. Number of participants in Africa/Stage 2 with solicited systemic events after the first study intervention administration
22. Number of participants in Africa/Stage 2 with solicited systemic events after the second study intervention administration
23. Number of participants in Africa/Stage 2 with solicited systemic events after the third study intervention administration
24. Number of participants in Africa/Stage 2 with unsolicited AEs after the first study intervention administration
25. Number of participants in Africa/Stage 2 with unsolicited AEs after the second study intervention administration
26. Number of participants in Africa/Stage 2 with unsolicited AEs after the third study intervention administration
27. Number of participants in Africa/Stage 2 with SAEs
28. Number of participants in Africa/Stage 2 with AEs/SAEs leading to withdrawal from the study and/or withholding doses of study intervention
29. Number of participants in Africa/Stage 2 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 8
30. Number of participants in Africa/Stage 2 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 64
31. Number of participants in Africa/Stage 2 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 176
32. Number of participants in Africa/Stage 2 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 29
33. Number of participants in Africa/Stage 2 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 85
34. Number of participants in Africa/Stage 2 with deviations from normal or baseline values for hematological, renal, and hepatic panels test results at Day 197
E.5.1.1Timepoint(s) of evaluation of this end point
1,4,18,21. During 7 days after the first* occurring at Day 1
2,5,19,22. During 7 days after the second* occurring at Day 57
3,6,20,23. During 7 days after the third* occurring at Day 169
7,24. During 28 days after the first* occurring at Day 1
8,25. During 28 days after the second* occurring at Day 57
9,26. During 28 days after the third* occurring at Day 169
10,11,27,28. From first* (Day 1) up to 28 days after the third* (Day 197)
12,29. At Day 8 (7 days after the first*)
13,30. At Day 64 (7 days after the second*)
14,31. At Day 176 (7 days after the third*)
15,32. At Day 29 (28 days after the first*)
16,33. At Day 85 (28 days after the second*)
17,34. At Day 197 (28 days after the third*)
* study intervention administration
E.5.2Secondary end point(s)
1. Number of participants with SAEs
2. Number of participants with AEs/SAEs leading to withdrawal from the study
3. Anti-serotype specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) in participants in Europe/Stage 1, and between group ratios
4. Anti-serotype specific IgG within-participant geometric mean ratios (GMRs) in participants in Europe/Stage 1
5. Number of participants in Europe/Stage 1 achieving, for each antigen (Ag), at least a 4-fold rise in anti-serotype specific IgG antibody concentration
6. Number of participants in Europe/Stage 1 with Anti-S. typhi Vi Ag IgG antibody concentrations equivalent to ≥ 4.3 micrograms per milliliter (µg/mL)
7. Anti-serotype specific IgG GMCs in participants in Africa/Stage 2, and between-group ratios
8. Anti-serotype specific IgG within-participant GMRs in participants in Africa/Stage 2
9. Number of participants in Africa/Stage 2 achieving, for each Ag, at least a 4 fold rise in anti serotype specific IgG antibody concentration
10. Number of participants in Africa/Stage 2 with Anti-S. Typhi Vi Ag IgG antibody concentrations equivalent to ≥ 4.3 µg/mL
E.5.2.1Timepoint(s) of evaluation of this end point
1,2. From 28 days after the third study intervention administration (Day 197) up to study end (Day 337)
3, 6, 7, 10. At Days 1, 57 and 169 (before each study intervention administration) and at Days 29, 85 and 197 (28 days after each study intervention administration)
4, 8. At 28 days after each study intervention administration compared to each study intervention administration baseline (Day 29 versus Day 1, Day 85 versus Day 57 and Day 197 versus Day 169)
5, 9. At Days 29, 85 and 197 (28 days after each study intervention administration) compared to Day 1 (first study intervention administration baseline)
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 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
Reactogenicity
Immunogenicity
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) Yes
E.7.1.1First administration to humans Yes
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 No
E.8.1.3Single blind No
E.8.1.4Double blind No
E.8.1.5Parallel group No
E.8.1.6Cross over No
E.8.1.7Other Yes
E.8.1.7.1Other trial design description
Data will be collected in an observer-blind manner; Sequential
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) Yes
E.8.2.2Placebo Yes
E.8.2.3Other No
E.8.2.4Number of treatment arms in the trial9
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 No
E.8.5The trial involves multiple Member States No
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
Belgium
Malawi
E.8.7Trial has a data monitoring committee Yes
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
The end of study (EoS) is defined as the date of the Last Subject Last Visit (LSLV) or date of last testing results released, whichever comes last. In the latter, EoS must be achieved no later than 8 months after LSLV.
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 years2
E.8.9.2In all countries concerned by the trial months2
E.8.9.2In all countries concerned by the trial days2
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: 155
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 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 state50
F.4.2 For a multinational trial
F.4.2.1In the EEA 50
F.4.2.2In the whole clinical trial 155
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 Decision2022-08-09
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2022-08-22
P. End of Trial
P.End of Trial StatusOngoing