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Also known as CV0701 mRNA COVID-19 Vaccine (Low dose)
CV0701 mRNA COVID-19 Vaccine · 1 trial · 2 indications
Assessed solicited administration site events included injection site redness (erythema), pain, swelling and lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm). Any = occurrence of the event regardless of intensity grade.
Assessed solicited systemic events included fever, chills, headache, myalgia (muscle pain), arthralgia (joint pain), and fatigue (tiredness). Fever is defined as body temperature is higher than or equal to (\>=) 38ºC; preferred location for measuring the temperature is oral. Any = occurrence of the event regardless of intensity grade.
An unsolicited AE is an AE that is either not included in the list of solicited events or can be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and nonserious AEs. Any = occurrence of the event regardless of intensity grade.
An SAE refers to any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or extends existing hospitalization, causes persistent or significant disability/incapacity, involves a congenital anomaly/birth defect in a participant's offspring, includes an abnormal pregnancy outcome, or occurs in any other situation per the investigator's judgement. An MAAE results in a visit to a medical professional, such as televisits, physician's office visits, urgent care visits, emergency rooms visits, or hospitalizations. AESIs are severe or non-severe predefined AEs of scientific and medical concern specific to the product/program. This study noted the following AESIs: potential immune-mediated disease (pIMDs), lab-confirmed moderate to severe COVID-19, myocarditis and pericarditis, anaphylaxis, or severe hypersensitivity within 24 hours post-intervention. "Any" indicates the occurrence of the event regardless of its intensity grade.
Assessed solicited administration site events included injection site redness (erythema), pain, swelling and lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm). Any = occurrence of the event regardless of intensity grade.
Assessed solicited systemic events included fever, chills, headache, myalgia (muscle pain), arthralgia (joint pain), and fatigue (tiredness). Fever is defined as body temperature \>= 38ºC; preferred location for measuring the temperature is oral. Any = occurrence of the event regardless of intensity grade.
An unsolicited AE is an AE that is either not included in the list of solicited events or can be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and nonserious AEs. Any = occurrence of the event regardless of intensity grade.
| Arm | Type | Description |
|---|---|---|
| Part A: CV0701 mRNA COVID-19 Vaccine (Low dose) | EXPERIMENTAL | Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the low-dose formulation on Day 1. |
| Part A: CV0701 mRNA COVID-19 Vaccine (Medium dose) | EXPERIMENTAL | Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the medium-dose formulation on Day 1. |
| Part A: CV0701 mRNA COVID-19 Vaccine (High dose) | EXPERIMENTAL | Participants received one dose of the CV0701 mRNA COVID-19 vaccine in the high-dose formulation on Day 1. |
| Part A: CV0601 mRNA COVID-19 vaccine | EXPERIMENTAL | Participants received one dose of the CV0601 mRNA COVID-19 vaccine on Day 1. |
| Part A: Control Vaccine | ACTIVE_COMPARATOR | Participants received one dose of the control vaccine at Day 1. |
| Part B: CV0801 mRNA COVID-19 vaccine (Maximum storage condition) | EXPERIMENTAL | Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Maximum storage condition. |
| Part B: CV0801 mRNA COVID-19 vaccine (Intermediate storage condition) | EXPERIMENTAL | Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Intermediate storage condition. |
| Part B: CV0801 mRNA COVID-19 vaccine (Baseline-control storage condition) | EXPERIMENTAL | Participants received one dose of the CV0801 mRNA COVID-19 vaccine on Day 1 under Baseline-control storage condition. |
| Name | Type | Description |
|---|---|---|
| CV0701 mRNA COVID-19 Vaccine (Low dose) | BIOLOGICAL | Study vaccine was administered as a single intramuscular injection. |
| CV0701 mRNA COVID-19 Vaccine (Medium dose) | BIOLOGICAL | Study vaccine was administered as a single intramuscular injection. |
| CV0701 mRNA COVID-19 Vaccine (High dose) | BIOLOGICAL | Study vaccine was administered as a single intramuscular injection. |
| CV0601 mRNA COVID-19 Vaccine | BIOLOGICAL | Study vaccine was administered as a single intramuscular injection. |
| Control vaccine | BIOLOGICAL | Study vaccine was administered as a single intramuscular injection. |
| CV0801 mRNA COVID-19 Vaccine | BIOLOGICAL | Study vaccine was administered as a single intramuscular injection. |
Participants are eligible to be included in the study only if all of the following criteria apply: 1. Is at least 18 years old and has achieved legal age according to local regulations in each participating country. 2. Must provide documented informed consent prior to any study procedures being per...
CV0701 mRNA COVID-19 Vaccine is an investigational mRNA vaccine developed by GSK plc for protection against SARS-CoV-2, the virus that causes COVID-19. It is a low-dose mRNA vaccine candidate studied in healthy adults aged 18 years and older. It is not an approved product and remains in clinical development.
CV0701 mRNA COVID-19 Vaccine is being developed for the prevention of SARS-CoV-2 infection and COVID-19. Its clinical program enrolled healthy adult volunteers 18 years of age and older in the United States and Australia. The vaccine is investigational and has not been authorized or approved for use.
CV0701 mRNA COVID-19 Vaccine is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program evaluating this low-dose mRNA COVID-19 vaccine candidate in healthy adult volunteers.
CV0701 mRNA COVID-19 Vaccine is in Phase 2 clinical development. Its Phase 2 trial has been completed, and no trials for this candidate are currently active. The vaccine is investigational and has not received FDA approval.
CV0701 mRNA COVID-19 Vaccine was evaluated in the Phase 2 trial NCT05960097, titled A Study on the Safety and Immune Response of Investigational COVID-19 mRNA Vaccines in Healthy Adults. The trial enrolled 692 participants across the United States and Australia, was randomized, double-blind, and active-controlled, and is now completed.
Yes. CV0701 mRNA COVID-19 Vaccine (Low dose) is another name for CV0701 mRNA COVID-19 Vaccine, the GSK mRNA COVID-19 vaccine candidate. Both names refer to the same investigational Phase 2 product studied in healthy adults for protection against SARS-CoV-2.