Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-24 @ 5:49 PM
NCT ID:
NCT07194668
Brief Summary:
This is a single blind randomised controlled trial. This study aims to assess whether a half-dose of the R21/Matrix-M malaria vaccine is as effective as the full dose in child and adults. The results will help optimize vaccine usage and improve malaria prevention strategies.
All participants will receive the same number of injections and will be randomly assigned to receive one of the followings:
1. The standard dose (10μg R21/50μg Matrix-M) of the malaria vaccine is administered in three doses over a two-month period (at Month 0, 1, and 2), followed by a booster dose at Month 11 (n=125).
or
2. A half dose (5μg R21/50μg Matrix-M) of the malaria vaccine is administered in three doses over a two-month period (at Month 0, 1, and 2), followed by a booster dose at Month 11.
If participant receive the half dose, it will come from one of two types of vaccine:
2a. 10 dose vials with adaptor Preservative Free (n=125) 2b. 10 dose vials with 2PE Preservative (n=125)
Clinical procedure for participants:
* Standardized symptom questionnaire
* Physical examination:
* Weight, height, pulse, blood pressure, respiratory rate, tympanic temperature.
* Spleen and liver size will be recorded if palpable.
* Pregnancy test (for female of child bearing potential)
* Venous blood collection (Pre-vaccination) 3mL
* Vaccination
Study:
NCT07194668
Study Brief:
Protocol Section:
NCT07194668