Trial No: 0
Date registered: 2023-04-11
Trial Status: Pending |
|
TRIAL DESCRIPTION |
Public title |
A Phase 2 Randomized, Double-blinded, Placebo-controlled Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of rVSV60- LASV-GPC Vaccine in Adults and Children |
Official scientific title |
A Phase 2 Randomized, Double-blinded, Placebo-controlled Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of rVSV60- LASV-GPC Vaccine in Adults and Children |
Brief summary describing the background
and objectives of the trial |
Lassa fever (LF) is a severe viral disease endemic to West African countries estimated to cause up
to 500 000 LF cases and 10 000 deaths annually. The main objective is to evaluate the safety and tolerability of rVSVĪG-LASV-GPC vaccine at 2 different dosage levels in adults, including PLWH, and in children |
Type of trial |
Prevention |
Acronym (If the trial has an acronym then
please provide) |
A Phase 2 Randomized, Double-blinded, Placebo-controlled Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of rVSV60- LASV-GPC Vaccine in Adults and Children |
Disease(s) or condition(s) being studied |
Lassa
|
Purpose of the trial |
|
Anticipated trial start date |
2023-06-15
|
Actual trial start date |
2023-07-05
|
Anticipated date of last follow up
|
2023-06-26
|
Actual date of last follow up
|
2025-10-31
|
Anticipated target sample size (number of
participants) |
310 |
Actual target sample size (number of
participants) |
310
|
Recruitment status |
Not yet recruiting
|
No |
Secondary ID |
Issuing authority/Trial register |
1 | 1 |
1 |
|