Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06702449 | A 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 | PHASE1 | RECRUITING | 448 | — | — | Nov 19, 2024 | May 31, 2027 | Apr 21, 2026 | 8 | United States, South Africa |
Solicited administration site events include pain, redness and swelling at administration site.
Solicited administration site events include pain, redness and swelling at administration site.
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.
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.
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.
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.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| Part 1 Group A1/A2 | EXPERIMENTAL | Participants receive candidate UTI vaccine low dose formulation 1 or placebo on Day 1 and Day 61. |
| Part 1 Group B1/B2 | EXPERIMENTAL | Participants receive candidate UTI vaccine low dose formulation 2, or placebo on Day 1 and Day 61. |
| Part 1 Group C1/C2 | EXPERIMENTAL | Participants receive candidate UTI vaccine medium dose formulation 1, or placebo on Day 1 and Day 61. |
| Part 1 Group D1/D2 | EXPERIMENTAL | Participants receive candidate UTI vaccine medium dose formulation 2, or placebo on Day 1 and Day 61. |
| Part 1 Group E1/E2 | EXPERIMENTAL | Participants receive candidate UTI vaccine high dose formulation 1, or placebo on Day 1 and Day 61. |
| Part 1 Group F1/F2 | EXPERIMENTAL | Participants receive candidate UTI vaccine high dose formulation 2, or placebo on Day 1 and Day 61. |
| Part 2 Group 1 | EXPERIMENTAL | 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. |
| Part 2 Group 2 | PLACEBO_COMPARATOR | Participants receive placebo on Day 1 and Day 61. |
| Name | Type | Description |
|---|---|---|
| Candidate UTI vaccine low dose formulation 1 | COMBINATION_PRODUCT | Candidate UTI vaccine low dose formulation 1 administered intramuscularly according to a 0, 2 months administration schedule. |
| Candidate UTI vaccine low dose formulation 2 | COMBINATION_PRODUCT | Candidate UTI vaccine low dose formulation 2 administered intramuscularly according to a 0, 2 months administration schedule. |
| Candidate UTI vaccine medium dose formulation 1 | COMBINATION_PRODUCT | Candidate UTI vaccine medium dose formulation 1 administered intramuscularly according to a 0, 2 months administration schedule. |
| Candidate UTI vaccine medium dose formulation 2 | COMBINATION_PRODUCT | Candidate UTI vaccine medium dose formulation 2 administered intramuscularly according to a 0, 2 months administration schedule. |
| Candidate UTI vaccine high dose formulation 1 | COMBINATION_PRODUCT | Candidate UTI vaccine high dose formulation 1 administered intramuscularly according to a 0, 2 months administration schedule. |
| Candidate UTI vaccine high dose formulation 2 | COMBINATION_PRODUCT | Candidate UTI vaccine high dose formulation 2 administered intramuscularly according to a 0, 2 months administration schedule. |
| Candidate UTI vaccine HTD formulation 2 | COMBINATION_PRODUCT | Candidate UTI vaccine HTD formulation 2 administered intramuscularly according to a 0, 2 months administration schedule. |
| Placebo | COMBINATION_PRODUCT | Placebo administered intramuscularly according to a 0, 2 months administration schedule. |
Inclusion Criteria: * Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * Written informed consent obtained from the participant prior to performance of any study-specific procedure. * Female participants of non-childbearing potential ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 2 | PHASE1 | Gepotidacin, Candidate UTI vaccine low dose formulation 1, Candidate UTI vaccine HTD formulation 2 |
| CorMedix Inc. | CRMD | 1 | PHASE2 | Meropenem-Vaborbactam, Antibiotics |
| Pfizer Inc. | PFE | 1 | — | Undisclosed |
| QIAGEN NV | QGEN | 1 | — | Undisclosed |