Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NTHi-10-AS01E · 1 trial · 1 indication
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Assessed solicited general symptoms are fatigue, gastrointestinal symptoms (included nausea, vomiting, diarrhoea and/or abdominal pain), headache, fever \[defined as oral temperature equal to or above 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade.
Assessed solicited general symptoms are fatigue, gastrointestinal symptoms (included nausea, vomiting, diarrhoea and/or abdominal pain), headache, fever (defined as oral temperature equal to or above 37.5 °C). Any = occurrence of the symptom regardless of intensity grade.
Assessed unsolicited AEs covered any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination.
Assessed unsolicited AEs covered any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination.
Assessed haematological parameters are complete blood cell count: Leukocytes \[white blood cells (WBC)\], differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatinine below or above the normal laboratory ranges tabulated by time point.
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity or are a congenital anomaly/ birth defect in the offspring of a study subject.
| Arm | Type | Description |
|---|---|---|
| 10-AS01E group | EXPERIMENTAL | Subjects in this group will receive the investigational NTHi vaccine. |
| Control group | PLACEBO_COMPARATOR | Subjects in this group will receive placebo. |
| Name | Type | Description |
|---|---|---|
| NTHi-10-AS01E | BIOLOGICAL | Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule. |
| NaCl Placebo | DRUG | Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule. |
Inclusion Criteria: * Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * A male or female between, and including, 40 and 80 years of age at the time of the first vaccination. * Written informed consent obtained from the subject. * Confirme...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| United Therapeutics Corporation | UTHR | 2 | PHASE3 | Ralinepag |
| AstraZeneca PLC | AZN | 2 | - | Undisclosed |
| Intuitive Surgical, Inc. | ISRG | 1 | - | Undisclosed |
| Creative Medical Technology Holdings, Inc. | CELZ | 1 | - | Undisclosed |
NTHi-10-AS01E is an investigational vaccine being studied for use in respiratory disorders, specifically in patients with chronic obstructive pulmonary disease (COPD) who have persistent airflow obstruction. It is being developed by GSK plc (ticker: GSK) and is currently in Phase 2 clinical development.
NTHi-10-AS01E is a monoclonal antibody vaccine designed to target NTHi, which stands for non-typeable Haemophilus influenzae. It is being evaluated for its safety, reactogenicity, and immunogenicity in patients with COPD and persistent airflow obstruction.
NTHi-10-AS01E is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The investigational vaccine is currently in Phase 2 clinical trials for respiratory disorders.
NTHi-10-AS01E is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 2 trial has been completed, and the vaccine is not currently in active clinical trials.
NTHi-10-AS01E was studied in a Phase 2 clinical trial with the identifier NCT02075541. This completed trial evaluated the safety, reactogenicity, and immunogenicity of the investigational vaccine GSK2838504A in COPD patients with persistent airflow obstruction. The trial enrolled 145 participants in Sweden and the United Kingdom.
Yes, NTHi-10-AS01E is the same as GSK2838504A. The Phase 2 clinical trial NCT02075541 refers to the investigational vaccine as GSK2838504A, which is the vaccine candidate being developed by GSK for respiratory disorders.