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Formulation 1: NTHi/Mcat vaccine GSK3277513A · 1 trial · 1 indication
Assessed solicited local symptoms are pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Assessed solicited general symptoms are fatigue, gastrointestinal symptoms, headache, myalgia, fever \[defined as oral temperature equal to or above 37.5 degrees Celsius (°C)\].
Assessed unsolicited AEs cover 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. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Assessed unsolicited AEs cover 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. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Assessed haematological parameters are complete blood cell count: Erythrocytes (RBC \[red blood cells\]), Leukocytes (WBC \[white blood cells\]), 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.
Assessed haematological parameters are complete blood cell count: Erythrocytes (RBC \[red blood cells\]), Leukocytes (WBC \[white blood cells\]), 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.
Assessed SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Potential immune-mediated diseases (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.
| Arm | Type | Description |
|---|---|---|
| GSK3277513A F1 Group | EXPERIMENTAL | Subjects, 18 - 40 years, receiving two doses of the non adjuvanted GSK Biologicals' NTHi Mcat investigational vaccine (GSK3277513A ) containing formulation 1 (F1) of PD, PE-PilA and UspA2 during Step 1 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. |
| GSK3277513A F2 Group | EXPERIMENTAL | Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 2 (F2) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. |
| GSK3277513A F3 Group | EXPERIMENTAL | Subjects, 50 - 70 years, receiving two doses of the GSK Biologicals' NTHi-Mcat investigational vaccine(GSK3277513A) containing formulation 3 (F3) (adjuvanted) of PD, PE-PilA and UspA2 during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. |
| Placebo Group | PLACEBO_COMPARATOR | Subjects, 18 - 40 years, receiving two doses of placebo (saline solution) during Step 1 of the study and subjects, 50 - 70 years, receiving two doses of placebo (saline solution) during Step 2 of the study. Intramuscular injection should be done in the deltoid of the non-dominant arm. In case it is not possible to inject in the non dominant arm, an injection in the dominant arm may be performed. |
| Name | Type | Description |
|---|---|---|
| Formulation 1 (plain): NTHi/Mcat vaccine GSK3277513A | BIOLOGICAL | 2 doses at Day 0 and Day 60, Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule |
| Formulation 2 (adjuvanted): NTHi/Mcat vaccine GSK3277513A | BIOLOGICAL | 2 doses at Day 0 and Day 60, Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule |
| Formulation 3 (adjuvanted): NTHi/Mcat vaccine GSK3339036A | BIOLOGICAL | 2 doses at Day 0 and Day 60, Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule |
| Placebo | DRUG | 2 doses at Day 0 and Day 60, Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule |
Inclusion Criteria: applicable for both Step 1 ((healthy volunteers) and Step 2 (\[ex-\]smokers) * Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol * Written informed consent obtained from the subject. * Female subjects of non-childbearing...
Top 1 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| United Therapeutics Corporation | UTHR | 2 | PHASE3 | Ralinepag, Tyvaso (treprostinil) |
The NTHi/Mcat vaccine GSK3277513A is an investigational vaccine developed by GSK plc for respiratory disorders. It is designed to target nontypeable Haemophilus influenzae (NTHi) and Moraxella catarrhalis (Mcat), two bacteria associated with respiratory tract infections. It is in Phase 1 clinical development and has been studied in a completed trial.
The NTHi/Mcat vaccine GSK3277513A is being developed for respiratory disorders. It is intended to prevent infections caused by nontypeable Haemophilus influenzae and Moraxella catarrhalis. It remains investigational and is not approved for use; its only completed clinical trial enrolled 120 healthy adult volunteers in Belgium.
GSK plc, which trades under the ticker GSK, is the developer of the NTHi/Mcat vaccine GSK3277513A. GSK conducted the Phase 1 study of the vaccine. The candidate is part of GSK's vaccine pipeline for respiratory disorders.
The NTHi/Mcat vaccine GSK3277513A is in Phase 1 clinical development. Its single Phase 1 trial has been completed, and no trials are currently active. The vaccine is investigational and has not been approved by the FDA or any other regulatory agency.
The NTHi/Mcat vaccine GSK3277513A has been studied in one completed Phase 1 trial, NCT02547974, titled a study to evaluate the safety, reactogenicity and immunogenicity of the investigational GSK Biologicals' GSK3277511A vaccine in adults. The trial enrolled 120 healthy volunteers aged 18 years and older in Belgium and was randomized, double-blind, and placebo-controlled.
Yes. The NTHi/Mcat vaccine GSK3277513A is also known as Formulation 1 (plain): NTHi/Mcat vaccine GSK3277513A. Both names refer to the same GSK plc investigational vaccine candidate for respiratory disorders, which has completed a single Phase 1 trial.