A Phase 1/2, randomized, controlled open label trial to evaluate the safety and immunogenicity of the rVSV?G-ZEBOV-GP Ebola Virus vaccine candidate in healthy children aged 1 to 12 years and in their adults and/or children relatives living in Lambaréné, Gabon.

The requested reference [87702c0c442157f91752a2d2aea18f51de4da4aa] no longer exists in our database. It has been replaced by the current reference: [9e495dab46c7013708c88b2723ea1098ed48fb74]

Authors
Category Primary study
Registry of TrialsPan African Clinical Trials Registry
Year 2020
INTERVENTION: control group Intervention group CONDITION: ; Ebola Ebola PRIMARY OUTCOME: • Concentration of rVSV in blood, urine, or saliva as detected by RT‐PCR at days 0, 1, 2/3, 7, 14, 21, 28.; The frequency and severity of adverse events (AEs) and/or serious adverse events (SAEs) associated with administration of =7.8 x 107 PFU rVSV?G‐ZEBOV‐GP measured as follow: ; • Frequency and severity of local signs and symptoms until day 14 post vaccination (solicited local symptoms). ; • Frequency and severity of systemic signs and symptoms until day 14 post vaccination (solicited systematic symptoms). ; • Frequency of adverse events (AEs), severity and assessed relationship to study vaccines until day 28 post vaccination (unsolicited AE).; • Detailed description of all serious adverse events (SAEs) until day 28 post vaccination.; • Values of safety laboratory measures at baseline and at follow‐up visits post‐vaccination until day 28 post vaccination (reference ranges will be age appropriate).; SECONDARY OUTCOME: • Detailed description of all serious adverse events (SAEs) until study last visit (at 365 days). ; • Concentration of rVSV?G‐ZEBOV‐GP in blood, urine, or saliva of vaccinees close contact persons as detected by RT‐PCR ; INCLUSION CRITERIA: 1. Healthy children, aged 1to 12 years(inclusive) at the time of screening 2. Willingness of parent or legal guardian to provide written informed consent prior to screening procedures. 3. Willingness of the relatives of the participant to provide written informed consent if they are = 18 years (or an assent when they are 13 to 17 years old). 4. Available, able, and willing to participate in all study visits and procedures
Epistemonikos ID: f0d7d6afcb4b0080d55782c96a7b6813f3449f93
First added on: Aug 24, 2024