Approval Probability
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ML Risk
NTHI vaccine GSK2838500A · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | Subjects in this group will receive formulation 1 of NTHi vaccine. |
| Group B | EXPERIMENTAL | Subjects in this group will receive formulation 2 of NTHi vaccine. |
| Group C | EXPERIMENTAL | Subjects in this group will receive formulation 3 of NTHi vaccine. |
| Group D | EXPERIMENTAL | Subjects in this group will receive formulation 4 of NTHi vaccine. |
| Group E | EXPERIMENTAL | Subjects in this group will receive formulation 5 of NTHi vaccine and a placebo. |
| Group F | EXPERIMENTAL | Subjects in this group will receive formulation 6 of NTHi vaccine and a placebo. |
| Group G | EXPERIMENTAL | Subjects in this group will receive formulation 7 of NTHi vaccine and a placebo. |
| Group H | EXPERIMENTAL | Subjects in this group will receive formulation 8 of NTHi vaccine and a placebo. |
| Group Placebo 1 | PLACEBO_COMPARATOR | Subjects in this group will receive placebo. |
| Group Placebo 2 | PLACEBO_COMPARATOR | Subjects in this group will receive placebo. |
| Name | Type | Description |
|---|---|---|
| NTHI vaccine GSK2838500A (formulation 1) | BIOLOGICAL | Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule. |
| NTHI vaccine GSK2838501A (formulation 2) | BIOLOGICAL | Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule. |
| NTHI vaccine GSK2838502A (formulation 3) | BIOLOGICAL | Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule. |
| NTHI vaccine GSK2838503A (formulation 4) | BIOLOGICAL | Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule. |
| NTHI vaccine GSK2838504A (formulation 5) | BIOLOGICAL | Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule. |
| NTHI vaccine GSK2838505A (formulation 6) | BIOLOGICAL | Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule. |
| NTHI vaccine GSK2838508A (formulation 7) | BIOLOGICAL | Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule. |
| NTHI vaccine GSK2838509A (formulation 8) | BIOLOGICAL | Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule. |
| Placebo comparator | 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, 50 and 70 years of age at the time of the first vaccination. * Written informed consent obtained from the subject. * Subjects...
| 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 vaccine GSK2838500A is an investigational vaccine being developed for respiratory disorders. It is designed to target non-typeable Haemophilus influenzae (NTHi), a bacterium associated with respiratory infections. The vaccine is intended for use in adults, particularly current and former smokers, to potentially prevent or reduce NTHi-related respiratory conditions.
NTHI vaccine GSK2838500A is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The company is conducting clinical research to evaluate the vaccine's safety and immunogenicity in adult populations.
NTHI vaccine GSK2838500A is in Phase 1 clinical development. It is an investigational vaccine, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety, reactogenicity, and immunogenicity in humans.
NTHI vaccine GSK2838500A has one completed Phase 1 clinical trial registered as NCT01678677. This study evaluated the safety, reactogenicity, and immunogenicity of the vaccine in current and former smokers aged 50 years and older. The trial enrolled 272 participants and was conducted in Belgium.
NTHI vaccine GSK2838500A is a monoclonal antibody-based vaccine designed to target non-typeable Haemophilus influenzae (NTHi). By eliciting an immune response against this bacterium, the vaccine aims to help prevent respiratory infections caused by NTHi, particularly in populations at higher risk such as smokers.
NTHI vaccine GSK2838500A is related to GSK2838497A, as indicated in the clinical trial title for NCT01678677. The study evaluated GSK Biologicals' non-typeable Haemophilus influenzae (NTHi) investigational vaccine GSK2838497A, which is the vaccine candidate being tested in this Phase 1 trial.