Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Candidate UTI vaccine low dose formulation 1 · 1 trial · 1 indication
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 |
| CorMedix Inc. | CRMD | 1 | PHASE2 | Meropenem-Vaborbactam, Antibiotics |
| Pfizer Inc. | PFE | 1 | - | Undisclosed |
| QIAGEN NV | QGEN | 1 | - | Undisclosed |
GSK's UTI vaccine low dose formulation 1 is an investigational vaccine being developed for the prevention of urinary tract infections (UTIs). It is currently in Phase 1 clinical development and is being studied in adults aged 18 to 64 years, including a clinical efficacy assessment in females in that age range.
The UTI vaccine low dose formulation 1 is being developed by GSK plc, which trades under the ticker GSK. The company is conducting a Phase 1 clinical trial to evaluate the vaccine's safety, immune response, and clinical efficacy in adults with urinary tract infections.
GSK's UTI vaccine low dose formulation 1 is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to assess safety and immunogenicity.
The UTI vaccine low dose formulation 1 is being studied in a Phase 1 clinical trial registered as NCT06702449. This randomized, double-blind, placebo-controlled trial is recruiting 448 participants in the United States and South Africa, and includes healthy volunteers aged 18 to 64 years.
No, the UTI vaccine low dose formulation 1 is not FDA approved. It is an investigational vaccine currently in Phase 1 clinical trials. The ongoing study is designed to evaluate its safety and immune response, and it has not yet completed clinical development or received marketing authorization.
The UTI vaccine low dose formulation 1 is a vaccine designed to elicit an immune response against urinary tract infections. As a vaccine, it is intended to train the immune system to recognize and fight the bacteria that cause UTIs, potentially reducing the risk of infection.