A Phase 1/2 interventional study of Candidate UTI vaccine low dose formulation 1 and Candidate UTI vaccine low dose formulation 2 in Urinary Tract Infections, sponsored by GlaxoSmithKline. Recruiting at 8 sites in 2 countries. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-21.
Sponsored by GlaxoSmithKline · Phase 1/2, Interventional, and Prevention
Among 14 studies in Urinary Tract Infections by GlaxoSmithKline — 4 open to participants now, 4 under way, none of them phase 3. Urinary Tract Infections · GlaxoSmithKline.
Among the 14 studies in Urinary Tract Infections by GlaxoSmithKline, this one is the 3rd largest by planned enrollment of the 13 interventional ones that give a count, is one of 2 that started in 2024, is the only one in phase 1/2, and was the 11th registered.
803 studies on the registry are indexed under Urinary Tract Infections; 133 are open to participants now.
Browse Urinary Tract Infections studies →4 of the 14 studies in Urinary Tract Infections by GlaxoSmithKline are open now, in 2 countries. Recruiting first, the newest first:
GlaxoSmithKline · Sites in United States
GlaxoSmithKline
GlaxoSmithKline · Sites in United States
By country, each count listing its studies:
Of the 84 Urinary Tract Infections studies recruiting now, 50 (60%) set no upper age limit and 23 (27%) stop at 75 or younger; 15 take children under 18; 17 take healthy volunteers.
This study: 18 Years to 64 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
14 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 3 · Phase 3 4 · Phase 4 1
First in 2011; this study’s year is marked. 2 started in 2024.
This study's planned enrollment of 448 is above the median of 131 across 560 interventional studies indexed under Urinary Tract Infections.
Median enrollment 61 across the 13 interventional studies, 614 across the 1 observational. Of the 10 that completed or were terminated, 9 (90%) have results posted.
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GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
3 of the studies in Urinary Tract Infections by GlaxoSmithKline that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07645235GlaxoSmithKlineA Study to Evaluate Gepotidacin Exposure in Breast Milk of Healthy Lactating Women | 2027-05-17 |
| NCT06702449GlaxoSmithKlineA Study on the Safety and Immune Response of a Urinary Tract Infection (UTI) Vaccine in Adults 18-64 Years of Age and Clinical Efficacy in Females 18-64 Years of Age | 2027-05-31 |
| NCT07371429GlaxoSmithKlineA Study in Pediatric Participants Aged ≥2 to <12 Years With a Suspected or Confirmed Bacterial Infection or Receiving Prophylaxis Antibiotics | 2027-08-23 |
Among the 14 studies in Urinary Tract Infections by GlaxoSmithKline, from their registry updates:
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The purpose of this study is to assess safety, reactogenicity, and immune response of the candidate UTI vaccine compared to placebo in adults between and including 18-64 years of age (YOA), and to perform a preliminary evaluation of clinical efficacy in females between and including 18-64 YOA.
This clinical trial consists of 2 parts. Part 1 will consist of antigen dose-escalation (start with least dose with gradual increase in dose) Safety Lead-In (SLI) in healthy participants. Part 2 (Proof of Principle [PoP]) will start after the safety review of all safety data in Part 1 and will consist of participants with history of at least 1 episode of urine culture confirmed E. coli UTI in the last 12 months prior to the study intervention administration.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Female participants of childbearing potential may be enrolled in the clinical study, if the participant:
Additional inclusion criterion only for participants in Part 1 of the study (SLI):
Additional inclusion criterion only for participants in Part 2 of the study (PoP):
Exclusion Criteria:
Medical conditions:
Additional exclusionary medical conditions only for participants in Part 1 of the study (SLI):
Additional exclusionary medical conditions only for participants in Part 2 of the study (PoP):
Chronic 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive candidate UTI vaccine low dose formulation 1 or placebo on Day 1 and Day 61.
Combination Product: Candidate UTI vaccine low dose formulation 1 · Combination Product: Placebo
Participants receive candidate UTI vaccine low dose formulation 2, or placebo on Day 1 and Day 61.
Combination Product: Candidate UTI vaccine low dose formulation 2 · Combination Product: Placebo
Participants receive candidate UTI vaccine medium dose formulation 1, or placebo on Day 1 and Day 61.
Combination Product: Candidate UTI vaccine medium dose formulation 1 · Combination Product: Placebo
Participants receive candidate UTI vaccine medium dose formulation 2, or placebo on Day 1 and Day 61.
Combination Product: Candidate UTI vaccine medium dose formulation 2 · Combination Product: Placebo
Participants receive candidate UTI vaccine high dose formulation 1, or placebo on Day 1 and Day 61.
Combination Product: Candidate UTI vaccine high dose formulation 1 · Combination Product: Placebo
Participants receive candidate UTI vaccine high dose formulation 2, or placebo on Day 1 and Day 61.
Combination Product: Candidate UTI vaccine high dose formulation 2 · Combination Product: Placebo
Participants receive the candidate UTI vaccine highest tolerated dose (HTD) formulation 2, tested in Part 1 of the study, on Day 1 and Day 61.
Combination Product: Candidate UTI vaccine HTD formulation 2
Participants receive placebo on Day 1 and Day 61.
Combination Product: Placebo
Candidate UTI vaccine low dose formulation 1 administered intramuscularly according to a 0, 2 months administration schedule.
Candidate UTI vaccine low dose formulation 2 administered intramuscularly according to a 0, 2 months administration schedule.
Candidate UTI vaccine medium dose formulation 1 administered intramuscularly according to a 0, 2 months administration schedule.
Candidate UTI vaccine medium dose formulation 2 administered intramuscularly according to a 0, 2 months administration schedule.
Candidate UTI vaccine high dose formulation 1 administered intramuscularly according to a 0, 2 months administration schedule.
Candidate UTI vaccine high dose formulation 2 administered intramuscularly according to a 0, 2 months administration schedule.
Candidate UTI vaccine HTD formulation 2 administered intramuscularly according to a 0, 2 months administration schedule.
Placebo administered intramuscularly according to a 0, 2 months administration schedule.
Part 1 and 2: Number of participants reporting solicited administration site adverse events (AEs)
Solicited administration site events include pain, redness and swelling at administration site.
Time frame: During the 7 days follow-up period post-Dose 1 (study intervention administered at Day 1)
Part 1 and 2: Number of participants reporting solicited administration site AEs
Solicited administration site events include pain, redness and swelling at administration site.
Time frame: During the 7 days follow-up period post-Dose 2 (study intervention administered at Day 61)
Part 1 and 2: Number of participants reporting solicited systemic AEs
Solicited systemic events include fever, headache, myalgia (muscle pain), arthralgia (joint pain), and fatigue (tiredness). Fever is defined as temperature greater than or equal to (\>=) 38.0°C and preferred location for measuring temperature is the axilla.
Time frame: During the 7 days follow-up period post-Dose 1 (study intervention administered at Day 1)
Part 1 and 2: Number of participants reporting solicited systemic AEs
Solicited systemic events include fever, headache, myalgia (muscle pain), arthralgia (joint pain), and fatigue (tiredness). Fever is defined as temperature \>=38.0°C and preferred location for measuring temperature is the axilla.
Time frame: During the 7 days follow-up period post-Dose 2 (study intervention administered at Day 61)
Part 1 and 2: Number of participants reporting unsolicited AEs
An unsolicited AE is an AE that is either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.
Time frame: During the 30 days follow-up period post-Dose 1 (study intervention administered at Day 1)
Part 1 and 2: Number of participants reporting unsolicited AEs
An unsolicited AE is an AE that is either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.
Time frame: During the 30 days follow-up period post-Dose 2 (study intervention administered at Day 61)
Part 1 and 2: Number of participants reporting any immediate unsolicited AEs
An unsolicited AE is an AE that is either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.
Time frame: During the 60 minutes follow-up period post-Dose 1 (study intervention administered at Day 1)
Part 1 and 2: Number of participants reporting any immediate unsolicited AEs
An unsolicited AE is an AE that is either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.
Time frame: During the 60 minutes follow-up period post-Dose 2 (study intervention administered at Day 61)
Part 1 and 2: Number of participants reporting serious adverse events (SAEs)
An SAE is defined as any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongs existing hospitalization, results in disability/incapacity or other medically significant events.
Time frame: From Day 1 (Dose 1 administration) until Day 426 (end of follow-up)
Part 1 and 2: Number of participants reporting potential immune-mediated diseases (pIMDs) leading to study withdrawal
pIMDs are a subset of Adverse Events of Special Interest (AESIs) that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
Time frame: From Day 1 (Dose 1 administration) until Day 426 (end of follow-up)
Part 1 and 2: Number of participants reporting medically-attended adverse events (MAAEs) leading to study withdrawal
An MAAE is defined as an unsolicited AE, such as a symptom or illness, which required hospitalization, or emergency room visit, or visit to/by a health care provider.
Time frame: From Day 1 (Dose 1 administration) until Day 426 (end of follow-up)
Part 1 and 2: Number of participants reporting AEs leading to study withdrawal
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
Time frame: From Day 1 (Dose 1 administration) until Day 426 (end of follow-up)
Part 1: Number of participants with hematology or biochemistry abnormalities or changes in baseline value
Time frame: At 7 days post-Dose 1 (Day 8) compared with baseline (pre-Dose 1, Day 1)
Part 1: Number of participants with hematology or biochemistry abnormalities or changes in baseline value
Time frame: At 7 days post-Dose 2 (Day 68) compared with Day 61 (pre-Dose 2)
Part 2: Incidence rate (IR) of the first occurrence of a urine culture confirmed UTI due to E. coli in the investigational group compared to the IR in placebo group
Time frame: From 14 days (Day 75) up to 12 months (Day 426) post-Dose 2
Part 2: IR of the total number of occurrences of urine culture confirmed UTIs due to E. coli in the investigational group compared to the IR in placebo group
Time frame: From 14 days (Day 75) up to 12 months (Day 426) post-Dose 2
Part 2: IR of the first occurrence of a urine culture confirmed UTI due to E. coli in the investigational group compared to the IR in placebo group
Time frame: From 14 days post-Dose 1 (Day 15) and up to the day before administration of Dose 2 (Day 60) or, for participants receiving only Dose 1, up to the end of the study (Day 426)
Part 2: IR of the total number of occurrences of urine culture confirmed UTIs due to E. coli in the investigational group compared to the IR in placebo group
Time frame: From 14 days post-Dose 1 (Day 15) and up to the day before administration of Dose 2 (Day 60) or, for participants receiving only Dose 1, up to the end of the study (Day 426)
Plan to share: Yes — Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
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.
Data sharing details ↗ · www.gsk-studyregister.com
No publications or documents are linked to this record.
Started Nov 2024 (actual). Primary completion is estimated for May 2027, 30 months after the start.
How these figures are worked out, and which studies are left out of them.
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