Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202306838192573 Date of Approval: 07/06/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A study to evaluate safety, reactogenicity, and immune response of GSK Vaccines Institute for Global Health invasive nontyphoidal Salmonella (iNTS) TCV vaccine against invasive nontyphoidal Salmonella and Typhoid Fever
Official scientific title 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
Brief summary describing the background and objectives of the trial In sSA, iNTS is one of the most common causes of bacteremia and reflects a major public health and socioeconomic burden. Infection with iNTS has been reported in sSA since the 1980s as a cause of child febrile illness and bacteremia, but often misdiagnosed as malaria [Feasey, 2012]. An estimated 59 100 iNTS deaths with more than half of them in children <5 years of age and a 14.5% case fatality rate have been reported in 2017 [Collaborators GBDN-TSID, 2019]. The iNTS disease causative agents are associated with increasing antimicrobial resistance (AMR) and are classified by the WHO as high priority pathogens for developing new antibiotics. The most common African S. Enterica serovars associated with iNTS disease are S. Enteritidis and S. Typhimurium, accounting for >90% of iNTS cases in sSA [Reddy, 2010]. There is no licensed human vaccine against iNTS and currently no preventive intervention. The purpose of this study is to assess the safety, reactogenicity, and immune response induced by the GlaxoSmithKline Biologicals SA (GSK) Vaccines Institute for Global Health (GVGH) invasive nontyphoidal Salmonella-typhoid conjugate (iNTS-TCV) candidate vaccine to be administered for the first time in humans. The study intervention will be evaluated in European adults in Stage 1 (a 2-step staggered design) followed by African adults in Stage 2.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied invasive nontyphoidal salmonellosis and typhoid fever
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 12/09/2022
Actual trial start date 13/09/2022
Anticipated date of last follow up 27/12/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 155
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
2021 005178 25 European Medicines Agency - EudraCT
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Central randomisation by phone/fax Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group iNTS TCV low dose Group Administration on days 1, 57, and 169. Participants 18 to 50 years of age in Stage 1 (Europe) randomized to receive 3 doses of iNTS-TCV low dose vaccine and 3 doses of saline solution, administered in different arms, at Days 1, 57, and 169. 4
Control Group iNTS GMMA and TCV low doses Group Administration on days 1, 57, and 169. Participants 18 to 50 years of age in Stage 1 (Europe) randomized to receive 3 doses of iNTS-GMMA low dose vaccine and 3 doses of TCV low dose vaccine, administered in different arms, at Days 1, 57, and 169. 4 Active-Treatment of Control Group
Control Group Placebo Step 1 Group Administration on days 1, 57, and 169. Participants 18 to 50 years of age in Stage 1 (Europe) randomized to receive 3 doses of placebo and 3 doses of saline solution, administered in different arms, at Days 1, 57, and 169. 2 Placebo
Experimental Group iNTS TCV full dose 1 Group Administration on days 1, 57, and 169. Participants 18 to 50 years of age in Stage 1 (Europe) randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution, administered in different arms, at Days 1, 57, and 169. 16
Control Group iNTS GMMA and TCV full doses 1 Group Administration on days 1, 57, and 169. Participants 18 to 50 years of age in Stage 1 (Europe) randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine, administered in different arms, at Days 1, 57, and 169. 16 Active-Treatment of Control Group
Control Group Placebo Step 2 Group Administration on days 1, 57, and 169. Participants 18 to 50 years of age in Stage 1 (Europe) randomized to receive 3 doses of placebo and 3 doses of saline solution, administered in different arms, at Days 1, 57, and 169. 8 Placebo
Experimental Group iNTS TCV full dose 2 Group Administration on days 1, 57, and 169. Participants 18 to 50 years of age in Stage 2 (Africa) randomized to receive 3 doses of iNTS-TCV full dose vaccine and 3 doses of saline solution, administered in different arms, at Days 1, 57, and 169. 45
Control Group iNTS GMMA and TCV full doses 2 Group Administration on days 1, 57, and 169. Participants 18 to 50 years of age in Stage 2 (Africa) randomized to receive 3 doses of iNTS-GMMA full dose vaccine and 3 doses of TCV full dose vaccine, administered in different arms, at Days 1, 57, and 169. 45 Active-Treatment of Control Group
Control Group Control Stage 2 Group Administration on days 1, 57 and 169. Participants 18 to 50 years of age in Stage 2 (Africa) randomized to receive one dose of GSK’s Meningococcal A, C, Y and W-135 conjugate vaccine administered at Day 1, one dose of GSK’s Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine administered at Day 57, one dose of Sanofi Pasteur’s Typhoid Vi polysaccharide vaccine administered at Day 169, and 3 doses of saline solution administered at Days 1, 57 and 169. 15 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participants, who, in the opinion of the Investigator, can and will comply with the requirements of the protocol (eg, completion of the pDiary cards, return for follow-up visits). • 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: − Has practiced adequate contraception (as indicated in Appendix 4) 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 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. • Known exposure to S. Typhi and NTS from 3 years pre 1st vaccination. • History of any reaction or hypersensitivity associated with any component of the study interventions. • Any confirmed or suspected immunosuppressive or immunodeficient condition, • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality • Recurrent history or uncontrolled neurological disorders or seizures. • Any clinically significant* hematological and/or biochemical laboratory abnormality. • Clinical conditions representing a contraindication to IM injections and/or blood draws. • Any behavioral or cognitive impairment or psychiatric disease that may interfere with the participant’s ability to participate in the study. • Confirmed positive COVID-19 from 28 days before the 1st dose • Acute or chronic illness which may be severe enough to preclude participation. • Any other clinical condition that, 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. • History of receiving any typhoid vaccine 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 from (D−30 to 1) before the 1st dose of study interventions, or planned use during the study. • A vaccine not foreseen by the study protocol administered 14D pre 1st dose to 28D post last dose, with the exception of flu vaccines or COVID-19 vaccine. • Administration of long-acting immune-modifying drugs any time during the study period. • Administration of immunoglobulins and/or any blood products or plasma derivatives From 3Mo before 1st admin or throughout the study. • Chronic admin of immunosuppressants or other immune-modifying drugs from 3 Mo before 1st dose. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 50 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 12/05/2023 Malawi National Health Science Research Committee
Ethics Committee Address
Street address City Postal code Country
P O Box 30377 Lilongwe 207203 Malawi
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Outcome measure 1 - Number of participants in Europe/Stage 1 with solicited administration site events after the first study intervention administration. The solicited administration site events are pain, redness, and swelling. During 7 days after the first study intervention administration occurring at Day 1
Primary Outcome Outcome measure 2 - Number of participants in Europe/Stage 1 with solicited administration site events after the second study intervention administration. The solicited administration site events are pain, redness, and swelling. During 7 days after the second study intervention administration occurring at Day 57
Primary Outcome Outcome measure 3 - Number of participants in Europe/Stage 1 with solicited administration site events after the third study intervention administration. The solicited administration site events are pain, redness, and swelling. During 7 days after the third study intervention administration occurring at Day 169
Primary Outcome Outcome measure 4 - Number of participants in Europe/Stage 1 with solicited systemic events after the first study intervention administration. The solicited systemic events are fever, headache, myalgia, arthralgia, and fatigue. Fever is defined as body temperature equal to or above (≥) 38.0 degrees Celsius (°C)/100.4 degrees Fahrenheit (°F). The preferred location for measuring temperature is the axilla. During 7 days after the first study intervention administration occurring at Day 1
Primary Outcome Outcome measure 5 - Number of participants in Europe/Stage 1 with solicited systemic events after the second study intervention administration. The solicited systemic events are fever, headache, myalgia, arthralgia, and fatigue. Fever is defined as body temperature ≥ 38.0 °C/100.4 °F. The preferred location for measuring temperature is the axilla. During 7 days after the second study intervention administration occurring at Day 57
Primary Outcome Outcome measure 6 - Number of participants in Europe/Stage 1 with solicited systemic events after the third study intervention administration. The solicited systemic events are fever, headache, myalgia, arthralgia, and fatigue. Fever is defined as body temperature ≥ 38.0 °C/100.4 °F. The preferred location for measuring temperature is the axilla. During 7 days after the third study intervention administration occurring at Day 169
Primary Outcome Outcome measure 7 - Number of participants in Europe/Stage 1 with unsolicited adverse events (AEs) after the first study intervention administration An unsolicited AE is an AE reported in addition to those solicited during the clinical study. Also, any ‘solicited’ symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited AE. During 28 days after the first study intervention administration occurring at Day 1
Primary Outcome Outcome measure 8 - Number of participants in Europe/Stage 1 with unsolicited adverse events (AEs) after the second study intervention administration. An unsolicited AE is an AE reported in addition to those solicited during the clinical study. Also, any ‘solicited’ symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited AE. During 28 days after the second study intervention administration occurring at Day 57
Primary Outcome Outcome measure 9 - Number of participants in Europe/Stage 1 with unsolicited adverse events (AEs) after the third study intervention administration. An unsolicited AE is an AE reported in addition to those solicited during the clinical study. Also, any ‘solicited’ symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited AE. During 28 days after the third study intervention administration occurring at Day 169
Primary Outcome Outcome measure 10 - Number of participants in Europe/Stage 1 with serious adverse events (SAE). An SAE is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, represents a congenital anomaly/birth defect in the offspring of a study participant or abnormal pregnancy outcomes. From first study intervention administration /Day 1/ up to 28 days after the third study intervention administration /Day 197/
Primary Outcome Outcome measure 11 - Number of participants in Europe/Stage 1 with AEs/SAEs leading to withdrawal from the study and/or withholding doses of study intervention. Any AEs including SAEs that leads to discontinuation of study intervention and/or the study is considered under this outcome measure. From first study intervention administration /Day 17/ up to 28 days after the third study intervention administration /Day 197/
Primary Outcome Outcome measure 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. Panel tests include measures of leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine. At Day 8 - 7 days after the first study intervention administration
Primary Outcome Outcome measure 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. Panel tests include measures of leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine. At Day 64 - 7 days after the second study intervention administration
Primary Outcome Outcome measure 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. Panel tests include measures of leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine. At Day 176 - 7 days after the third study intervention administration
Primary Outcome Outcome measure 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 2. Panel tests include measures of leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine. At Day 29 - 28 days after the first study intervention administration
Primary Outcome Outcome measure 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. Panel tests include measures of leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine. At Day 85 - 28 days after the second study intervention administration
Primary Outcome Outcome measure 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. Panel tests include measures of leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine. At Day 197 - 28 days after the third study intervention administration
Primary Outcome Outcome measure 18 - Number of participants in Africa/Stage 2 with solicited administration site events after the first study intervention administration. The solicited administration site events are pain, redness, and swelling. During 7 days after the first study intervention administration occurring at Day 1
Primary Outcome Outcome measure 19 - Number of participants in Africa/Stage 2 with solicited administration site events after the second study intervention administration. The solicited administration site events are pain, redness, and swelling. During 7 days after the second study intervention administration occurring at Day 57
Primary Outcome Outcome measure 20 - Number of participants in Africa/Stage 2 with solicited administration site events after the third study intervention administration. The solicited administration site events are pain, redness, and swelling. During 7 days after the third study intervention administration occurring at Day 169
Primary Outcome Outcome measure 21 - Number of participants in Africa/Stage 2 with solicited systemic events after the first study intervention administration. The solicited systemic events are fever, headache, myalgia, arthralgia, and fatigue. Fever is defined as body temperature ≥ 38.0 °C/100.4 °F. The preferred location for measuring temperature is the axilla. During 7 days after the first study intervention administration occurring at Day 1
Primary Outcome Outcome measure 22 - Number of participants in Africa/Stage 2 with solicited systemic events after the second study intervention administration. The solicited systemic events are fever, headache, myalgia, arthralgia, and fatigue. Fever is defined as body temperature ≥ 38.0 °C/100.4 °F. The preferred location for measuring temperature is the axilla. During 7 days after the second study intervention administration occurring at Day 57
Primary Outcome Outcome measure 23 - Number of participants in Africa/Stage 2 with solicited systemic events after the third study intervention administration. The solicited systemic events are fever, headache, myalgia, arthralgia, and fatigue. Fever is defined as body temperature ≥ 38.0 °C/100.4 °F. The preferred location for measuring temperature is the axilla. During 7 days after the third study intervention administration occurring at Day 169
Primary Outcome Outcome measure 24 - Number of participants in Africa/Stage 2 with unsolicited adverse events (AEs) after the first study intervention administration. An unsolicited AE is an AE reported in addition to those solicited during the clinical study. Also, any ‘solicited’ symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited AE. During 28 days after the first study intervention administration occurring at Day 1
Primary Outcome Outcome measure 25 - Number of participants in Africa/Stage 2 with unsolicited adverse events (AEs) after the second study intervention administration. An unsolicited AE is an AE reported in addition to those solicited during the clinical study. Also, any ‘solicited’ symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited AE. During 28 days after the second study intervention administration occurring at Day 57
Primary Outcome Outcome measure 26 - Number of participants in Africa/Stage 2 with unsolicited adverse events (AEs) after the third study intervention administration. Any unsolicited AE is an AE reported in addition to those solicited during the clinical study. Also, any ‘solicited’ symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited AE. During 28 days after the third study intervention administration occurring at Day 169
Primary Outcome Outcome measure 27 - Number of participants in Africa/Stage 2 with SAEs. An SAE is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, represents a congenital anomaly/birth defect in the offspring of a study participant or abnormal pregnancy outcomes. From first study intervention administration /Day 1/ up to 28 days after the third study intervention administration /Day 197/
Primary Outcome Outcome measure 28 - Number of participants in Africa/Stage 2 with AEs/SAEs leading to withdrawal from the study and/or withholding doses of study intervention. Any AEs including SAEs that leads to discontinuation of study intervention and/or the study is considered under this outcome measure. From first study intervention administration /Day 1/ up to 28 days after the third study intervention /Day 197/
Primary Outcome Outcome measure 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. Panel tests include measures leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine. At Day 8 - 7 days after the first study intervention administration
Primary Outcome Outcome measure 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. Panel tests include measures leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine. At Day 64 - 7 days after the second study intervention administration
Primary Outcome Outcome measure 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. Panel tests include measures leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine. At Day 176 - 7 days after the third study intervention administration
Primary Outcome Outcome measure 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. Panel tests include measures leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine. At Day 29 - 28 days after the first study intervention administration
Primary Outcome Outcome measure 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. Panel tests include measures leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine. At Day 85 - 28 days after the second study intervention administration
Primary Outcome Outcome measure 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. Panel tests include measures leukocytes, platelets, hemoglobin, alanine aminotransferase, aspartate aminotransferase, urea/blood urea nitrogen, and creatinine. At Day 197 - 28 days after the third study intervention administration
Secondary Outcome Outcome measure 35 - Number of participants with serious adverse events (SAEs). An SAE is defined as any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, represents a congenital anomaly/birth defect in the offspring of a study participant or abnormal pregnancy outcomes. From 28 days after the third study intervention administration /Day 197/ up to study end /Day 337/
Secondary Outcome Outcome measure 36 - Number of participants with AEs/SAEs leading to withdrawal from the study Any AEs including SAEs that leads to discontinuation of the study is considered under this outcome measure. From 28 days after third study intervention administration /Day 197/ up to Day 337
Secondary Outcome Outcome measure 37 - Anti-serotype specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) in participants in Europe/Stage 1, and between group ratios. Anti-S. Typhi Vi antigen (Ag) total IgG, Anti-S. Typhimurium O Ag total IgG, Anti S. Enteritidis O Ag total IgG GMCs and between group ratios are assessed. 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
Secondary Outcome Outcome measure 38 - Anti-serotype specific immunoglobulin G (IgG) within-participant geometric mean ratios (GMRs) in participants in Europe/Stage. Anti-S. Typhi Vi antigen (Ag) total IgG, Anti-S. Typhimurium O Ag total IgG, Anti S. Enteritidis O Ag total IgG within-participant GMRs are assessed. 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/
Secondary Outcome Outcome measure 39 - Number of participants in Europe/Stage 1 achieving, for each antigen (Ag), at least a 4 fold rise in anti serotype specific immunoglobulin G (IgG) antibody concentration. Anti-S. Typhi Vi Ag total IgG, Anti-S. Typhimurium O Ag total IgG, Anti-S. Enteritidis O Ag total IgG antibody concentrations are assessed. At Days 29, 85, and 197 /28 days after each study intervention administration/ compared to Day 1 /first study intervention administration baseline/
Secondary Outcome Outcome measure 40 - 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) 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/
Secondary Outcome Outcome measure 41 - Anti-serotype specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) in participants in Africa/Stage 2, and between-group ratio. Anti-S. Typhi Vi Ag total IgG, Anti-S. Typhimurium O Ag total IgG, Anti S. Enteritidis O Ag total IgG GMCs and between-group ratios are assessed. 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/
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Antwerp Centre for Evaluation of Vaccination CEV Vaccinopolis Drie Eikenstraat 663 Antwerp 2650 Belgium
Malawi Liverpool Wellcome Trust Clinical Research Programme. Queen Elizabeth Central Hospital P.O. Box 30096 Chichiri Blantyre Malawi
FUNDING SOURCES
Name of source Street address City Postal code Country
Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator CARB X at Boston University 771e Commonwealth Avenue Boston United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor GlaxoSmithKline Biologicals SA Rue de l Institut 89 Rixensart 1330 Belgium Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Biomedical Advanced Research and Development Authority 200 Independence Avenue Washington DC 20201 United States of America
Wellcome Trust 215 Euston Road London NW1 2BE United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Melita Gordon Magordon@liverpool.ac.uk +2651874628 P.O. Box 30096 Chichiri
City Postal code Country Position/Affiliation
Blantyre Malawi Head of Malawi Liverpool Wellcome Trust Salmonella and Enterics Group
Role Name Email Phone Street address
Scientific Enquiries Usman Nakakana usman.n.nakakana@gsk.com +393461152021 Via Fiorentina 1
City Postal code Country Position/Affiliation
Siena Italy Project Physician GSK Vaccines Institute for Global Health
Role Name Email Phone Street address
Public Enquiries Felistas Mwakiseghile fmwakiseghile@mlw.mw +2650993384268 P.O. Box 30096 Chichiri
City Postal code Country Position/Affiliation
Blantyre Malawi Trial Coordinator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Plan to Share IPD: Yes Plan Description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK’s data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/ Supporting Materials: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications. Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months. URL: https://www.gsk.com/en-gb/innovation/trials/data-transparency/ Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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