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Also known as GSK Biologicals' investigational TB vaccine (GSK692342)
GSK Biologicals' investigational TB vaccine · 1 trial · 2 indications
The incidence rate of definite pulmonary TB disease (or 100 Person-years rate) was calculated as the number of subjects reporting at least one case (n) in a group, over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100. Case definition 1 = subject with clinical suspicion of pulmonary TB disease\*, with Mycobacterium tuberculosis (Mtb) complex identified from sputum specimen, taken before initiation of TB treatment, by Xpert MTB/RIF (Nucleic Acid Amplification Test to detect Mtb complex and resistance to rifampicin in sputum samples) and/or microbiological culture and confirmed Human Immunodeficiency Virus (HIV)-negative at the time of TB diagnosis. \*Clinical suspicion of pulmonary TB defined as subject presenting with 1 or more of the following symptoms: unexplained cough \> 2 weeks, unexplained fever \> 1 week, night sweats, unintentional weight loss, pleuritic chest pains, haemoptysis, fatigue or shortness of breath on exertion.
| Arm | Type | Description |
|---|---|---|
| M72AS01 Group | EXPERIMENTAL | Subjects, between, and including, 18 and 50 years of age, who received 2 doses of M72/AS01E according to random assignment, one month apart (Day 0 and Day 30) by intramuscular injection in the deltoid region of the arm. |
| Control group | PLACEBO_COMPARATOR | Subjects, between, and including,18 and 50 years of age, who received 2 doses of Placebo according to random assignment, one month apart (Day 0 and Day 30) by intramuscular injection in the deltoid region of the arm. |
| Name | Type | Description |
|---|---|---|
| GSK Biologicals' investigational TB vaccine (GSK692342) | BIOLOGICAL | 2 doses administered intramuscularly in the deltoid region of the arm. |
| Placebo | BIOLOGICAL | 2 doses administered intramuscularly in the deltoid region of the arm. |
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, 18 and 50 years of age at the time of obtaining informed consent. * Written (or thumb printed and witnessed) informed consent...
Top 2 of 3 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| BioNTech SE Sponsored ADR | BNTX | 1 | PHASE1 | BNT164a1, BNT164b1 |
| GSK plc Sponsored ADR | GSK | 1 | PHASE1 | Ganfeborole |
GSK Biologicals' investigational TB vaccine, also known as GSK692342, is a vaccine candidate being developed by GSK plc for the prevention of tuberculosis. It is an investigational product and has been studied in a Phase 2 clinical trial in adults.
GSK Biologicals' investigational TB vaccine is being developed for the prevention of tuberculosis. It is intended for use in adults, and the clinical program has evaluated it in countries including Kenya, South Africa, and Zambia.
GSK Biologicals' investigational TB vaccine is developed by GSK plc, which trades under the ticker GSK. GSK Biologicals is the vaccines unit of GSK plc.
GSK Biologicals' investigational TB vaccine is in Phase 2 development. It is an investigational vaccine and is not approved for use. The Phase 2 trial has been completed.
GSK Biologicals' investigational TB vaccine has been studied in one Phase 2 clinical trial, NCT01755598, titled Study to Evaluate the Efficacy of GlaxoSmithKline (GSK) Biologicals' Candidate Tuberculosis (TB) Vaccine in Adults. The trial enrolled 3,575 participants and is completed.
Yes, GSK Biologicals' investigational TB vaccine is also known as GSK692342. Both names refer to the same investigational vaccine candidate developed by GSK plc for tuberculosis.