GSKVX000000044501 for Urinary tract infection

Inclusion criteria

• {"criterion_text":"- \tParticipants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol.\n- \tWritten informed consent obtained from the participant prior to performance of any study-specific procedure.\n- \tFemale participants of non-childbearing potential may be enrolled in the clinical study.\n- \tFemale participants of childbearing potential may be enrolled in the clinical study, if the participant:\n- \thas practiced adequate contraception for 1 month prior to study intervention administration, and\n- \thas a negative pregnancy test on the day of study intervention administration, and\n- \thas agreed to continue adequate contraception during the entire treatment period and for at least 1 month after completion of the study intervention administration series.\n- \tBlood sample for simultaneous follicle stimulating hormone (FSH) and estradiol levels may be collected.\n- \tAdditional inclusion criterion only for participants in Part 1 of the study (SLI): •\tFemale and male between and including 18 through 64 YOA at the time of ICF signature.\n- \tAdditional inclusion criterion only for participants in Part 1 of the study (SLI): •\tHealthy participants, according to medical history, laboratory assessment and clinical examination at Screening Visit.\n- \tAdditional inclusion criterion only for participants in Part 2 of the study (PoP): •\tFemales between and including 18 through 64 YOA at the time of ICF signature.\n- \tAdditional inclusion criterion only for participants in Part 2 of the study (PoP): •\tParticipants with documented history of at least 1 episode of urine culture confirmed E. coli uncomplicated UTI in the last 12 months prior to study vaccine administration."}

Exclusion criteria

• {"criterion_text":"- \tHistory of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).\n- \tAny confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.\n- \tHypersensitivity to latex.\n- \tHistory of pIMD.\n- \tAcute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.\n- \tHistory of endocrinologic, hematologic, metabolic, urologic, dermatologic, or gastrointestinal conditions that, in the opinion of the investigator, places the participant at unacceptable risk or would make adhering to study procedures for the duration of the study difficult.\n- \tRecurrent history or uncontrolled neurological disorders or any neuroinflammatory (including, but not limited to demyelinating disorders, encephalitis or myelitis of any origin), congenital neurological conditions, encephalopathies, or seizures.\n- \tAny 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.\n- \tCondition that in the judgment of the investigator would make intramuscular injection unsafe.\n- \tAny other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.\n- \tAdditional exclusionary medical conditions only for participants in Part 1 of the study (SLI): •\tAny clinically significant hematologic and/or biochemical laboratory abnormality at Screening Visit.\n- \tThe participant has UTI that is known or suspected to be due to fungal, parasitic, or viral pathogens; or known or suspected to be due to Pseudomonas aeruginosa or any Enterobacter species.\n- \tThe participant has symptoms known or suspected to be caused by another disease process, such as asymptomatic bacteriuria, overactive bladder, chronic incontinence, or chronic interstitial cystitis, that may interfere with the clinical efficacy assessments.\n- \tThe participant has an anatomical or physiological anomaly that predisposes the participant to UTIs or may be a source of persistent bacterial colonization, including calculi, obstruction or stricture of the urinary tract, primary renal disease or neurogenic bladder, or the participant has a history of anatomical or functional abnormalities of the urinary tract.\n- \tThe participant has an indwelling catheter, nephrostomy, ureteral stent, or other foreign material in the urinary tract.\n- \tThe participant who, in the opinion of the investigator, has an otherwise complicated UTI or has an active upper UTI.\n- \tUse of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study intervention(s) during the period beginning 30 days before the first dose of study intervention(s) (Day -29 to Day 1), or their planned use during the study period.\n- \tPlanned administration and/or administration of a vaccine not foreseen by the study protocol in the period starting 15 days before the first dose and ending 15 days after the last dose of study intervention(s) administration.\n- \tAdministration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the study intervention or planned administration during the study period.\n- \tChronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune modifying treatments at any time up to the end of the study.\n- \tUp to 3 months prior to the study intervention administration:\n- \tFor corticosteroids, this will mean prednisone equivalent >=20 mg/day for adult participants. Inhaled and topical steroids are allowed.\n- \tUp to 3 months prior to study intervention administration: long-acting immune-modifying drugs including among others immunotherapy (e.g., TNF-inhibitors), monoclonal antibodies, antitumoral medication.\n- \tConcurrently 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, vaccine or invasive medical device).\n- \tPregnant or lactating female participant.\n- \tFemale participant planning to become pregnant or planning to discontinue contraceptive precautions before 1 month after completion of the study intervention administration series.\n- \tHistory of chronic alcohol consumption* and/or drug abuse, based on investigator judgment.\n- \tPersons under guardianship or trusteeship.\n- \tPersons deprived of liberty.\n- \tAny study personnel or their immediate dependents, family, or household members."}

Primary endpoints

• {"endpoint_text":"- For participants in both parts of the study (Part 1 [SLI] and Part 2 [PoP]), occurrence of: •\tsolicited administration site and systemic AEs during the 7 days post-Dose 1 and post-Dose 2, •\tany unsolicited AEs during the 30 days post-Dose 1 and post Dose 2, •\tany immediate unsolicited AEs in the 60 minutes post-Dose 1 and post-Dose 2. •\tSAEs, pIMDs, MAAEs, and AEs leading to study withdrawal until Day 426 (i.e., end of follow-up).","definition_or_measurement_approach":"Solicited local and systemic AEs collected during the 7-day post-dose windows; unsolicited AEs collected during 30-day post-dose windows; immediate unsolicited AEs captured in the 60 minutes post-dose; SAEs, pIMDs, MAAEs and AEs leading to withdrawal collected through Day 426 (end of follow-up)."}
• {"endpoint_text":"- For participants in the Part 1 of the study (SLI): •\tOccurrence of hematological and biochemical laboratory abnormalities, and changes from the baseline values, at 7 days after the day of Dose 1 and Dose 2 compared to pre-dose values (i.e., on Day 8 and Day 68, compared to Day 1# and Day 61, respectively).","definition_or_measurement_approach":"Laboratory hematology and biochemistry assessments comparing Day 8 vs Day 1 and Day 68 vs Day 61 to identify abnormalities and changes from baseline."}
• {"endpoint_text":"- For participants in the Part 2 of the study (PoP): •\tFirst occurrence of a urine culture confirmed UTI due to E. coli from 14 days (Day 75) up to 12 months (Day 426) post-Dose 2.","definition_or_measurement_approach":"First urine-culture-confirmed UTI due to E. coli occurring between Day 75 and Day 426 post-Dose 2 (i.e., microbiologically confirmed endpoint within the specified time window)."}

Methods

• Use of third-party recruitment partners (e.g., Autocruitment LLC, Live Uti Free Limited) for subject recruitment (documents and thirdParty entries indicate subject recruitment responsibilities).
• Digital recruitment materials: study landing pages, website design, social media campaigns, browser ads, and online 'Find a Study Site' pages (document list includes 'Website Design', 'Landing Page', 'Social Media', 'Browser' and related materials).
• Printed materials and community outreach: flyers, posters, tri-fold brochures and poster materials for GP/hospital settings (documents: K2_Flyer, K2_Poster, K2_Tri Fold Brochure, K2_Poster_GP etc.).
• Phone prescreening / phone screening: documented phone screen materials (e.g., 'K2_AutoCruitment_PhoneScreen_EN' and 'K2_AutoCruitment_PhoneScreen_*' files).
• Prescreen webforms and online prescreen questionnaires (documents: 'K2_Prescreening Webform_CEVAC', 'K2_Prescreening Form_CEVAC').
• Local site recruitment via participating hospitals/GP practices (site lists and GP poster materials indicate site-level recruitment).
• Use of patient advocacy/engagement groups to support recruitment and help desk support (documents and thirdParties entries indicate Live Uti Free and help desk/manual responses).

Belgium

Earliest CTIS Part Ii Submission Date

02-04-2025

Latest Decision Or Authorization Date

17-10-2025

Processing Time Days

199

Number Of Sites

6

Number Of Participants

110

Spain

Earliest CTIS Part Ii Submission Date

04-04-2025

Latest Decision Or Authorization Date

26-03-2026

Processing Time Days

357

Number Of Sites

12

Number Of Participants

90

Primary sponsor

Full Name

GlaxoSmithKline Biologicals

Organisation Type

Pharmaceutical company

Country Of Registered Address

Belgium

Contract research organisations

Name

Sermes CRO

Responsibilities

Patient fee reimbursement

Name

WCG Clinical Inc.

Responsibilities

Site Staff Training platform providers.

Name

RWS Life Sciences Inc.

Responsibilities

Study document translation services

Third parties

• {"country":"United States","full_name":"Autocruitment LLC","duties_or_roles":"Subject Recruitment","organisation_type":"Patient organisation/association"}
• {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Site Staff Training platform providers.","organisation_type":"Pharmaceutical company"}
• {"country":"Spain","full_name":"Alcura Health Espana S.A.","duties_or_roles":"Medicine product destruction","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"Study document translation services","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Subject compensation","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Corevitas LLC","duties_or_roles":"Study Participant Feed Back Questionnaire service provider","organisation_type":"Pharmaceutical company"}
• {"country":"Spain","full_name":"Sermes CRO","duties_or_roles":"Patient fee reimbursement","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Live Uti Free Limited","duties_or_roles":"Subject Recruitment","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medable Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}