A Phase 3 Study of XXXX Candidate Vaccine to Prevent Norovirus Acute Gastroenteritis in Adults
Summary:
Summary:
Participants will be randomly assigned in a 1:1 ratio to receive a single injection of either 50 μg of the XXXX vaccine or placebo.
Participants will be randomly assigned in a 1:1 ratio to receive a single injection of either 50 μg of the XXXX vaccine or placebo.
Enrollment will be stratified by age (18 to 59 years of age; 60 to 69 years of age; 70 to 79 years of age; and ≥80 years of age) with target enrollment of approximately 30% of participants 18 to 59 years of age, 30% of participants 60 to 69 years of age, 30% of participants 70 to 79 years of age, and 10% of participants ≥80 years of age.
Enrollment will be stratified by age (18 to 59 years of age; 60 to 69 years of age; 70 to 79 years of age; and ≥80 years of age) with target enrollment of approximately 30% of participants 18 to 59 years of age, 30% of participants 60 to 69 years of age, 30% of participants 70 to 79 years of age, and 10% of participants ≥80 years of age.
Type of study (PIC, Recruiting):
Type of study (PIC, Recruiting):
Recruiting
Commercial Study - Site Identification form required to be completed, please find Site ID form uploaded to study documents link below.
Commercial Study - Site Identification form required to be completed, please find Site ID form uploaded to study documents link below.
If you have been contacted directly by sponsor/CRO to take part in this study, you are NOT required to complete the NIHR Site Identification form. Please confirm by return email that you are in direct contact with sponsor/CRO and are completing their questionnaire. If you require any support with this process, please let us know and we would be happy to discuss.
If you have been contacted directly by sponsor/CRO to take part in this study, you are NOT required to complete the NIHR Site Identification form. Please confirm by return email that you are in direct contact with sponsor/CRO and are completing their questionnaire. If you require any support with this process, please let us know and we would be happy to discuss.
Recruitment Duration:
Recruitment Duration:
01/10/2024 to 20/12/2024
Practice Activity:
Practice Activity:
See Part B
Practice Eligibility Criteria:
Practice Eligibility Criteria:
GP Practices in the East Midlands
Practice Target:
Practice Target:
To be confirmed based on interest from UK sites
Is this Study Applicable for RSI Scheme?
Is this Study Applicable for RSI Scheme?
Yes, applicable for RSI scheme
Research Costs:
Research Costs:
Commercial research studies follow a national tariff guideline. Click here for more information on the tariff or download the tariff by clicking here
Commercial research studies follow a national tariff guideline. Click here for more information on the tariff or download the tariff by clicking here