Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05130398 | Safety and Immunogenicity of the rVSVΔG-ZEBOV-GP Ebola Virus Vaccine Candidate in Children Living in Lambaréné, Gabon | PHASE1 | COMPLETED | 120 | — | — | Apr 9, 2021 | Aug 9, 2022 | Apr 20, 2023 | 1 | Gabon |
Concentration of rVSVΔG-ZEBOV-GP in blood, urine, or saliva as detected by RT-PCR and expressed as copy number in vaccinees
Proportion (percent) of participants experiencing sollicited adverse events in vaccinees groups
Proportion (percent ) of participant experiencing unsollicited adverse event (AEs) and serious adverse events (SAEs) and relative risk of AEs and SAEs in participant by vaccine groups
| Arm | Type | Description |
|---|---|---|
| the rVSVΔG-ZEBOV-GP vaccine | EXPERIMENTAL | Participants of the experimental arm will receive a single intramuscular dose of ≥7.8 x 107 pfu of the rVSVΔG-ZEBOV-GP vaccine. In total, 80 participants will receive the experimental vaccine: 40 participants aged 6-12 years and 40 aged 1-5 years. |
| The Chikenpox or Varicella (Varilix) vaccine | ACTIVE_COMPARATOR | The control arm consists of the chickenpox vaccine. Forty children will receive a single subcutaneous dose of Varilix, the active comparator vaccine, 20 aged 6-12 years and 20 aged 1-5 years |
| Fibre and equilibrate diet | EXPERIMENTAL | Participants were assigned to receive two meals daily ( breakfast and lunch) for 21 days. About 30 children are randomly assigned to fibre and equilibrate diet. |
| Active detection and treatment of pathogens according to standard of care | EXPERIMENTAL | The following pathogens: P. falciparum, Ascaris lumbricoides, Trichuris trichiura, Necator americanus, intestinal protozoa, BG+, BG- colonies and pathogens, SARS-CoV2 are actively detected and treated according to the standard of care every month. About 30 children are randomly assigned to this arm. |
| Diet plus Active detection and treatment of pathogens according to standard of care | EXPERIMENTAL | Participants were assigned to receive two meals daily ( breakfast and lunch) for 21 days and concomitantly assigned to active detection of P. falciparum, Ascaris lumbricoides, Trichuris trichiura, Necator americanus, intestinal protozoa, BG+, BG- colonies and pathogens, SARS-CoV2 every month. About 30 children are assigned to receive combined interventions |
| No diet and no pathogen detection | PLACEBO_COMPARATOR | About 30 children received no diet and no active detection of pathogens |
| Name | Type | Description |
|---|---|---|
| rVSVΔG-ZEBOV-GP, V920 | BIOLOGICAL | The experimental vaccine is the rVSVΔG-ZEBOV-GP, an Ebola vaccine. |
| Fibre and equilibrate breakfast and lunch | DIETARY_SUPPLEMENT | Participants receive fibres and caloric equilibrate diet during breakfast and lunch every day for 21 consecutive days. |
| Active detection and treatment of pathogens | DIAGNOSTIC_TEST | Monthly diagnostic and treatment of childhood infections Active detection and treatment of pathogens. |
| Fibre and equilibrate breakfast and lunch plus Active detection and treatment of pathogens | COMBINATION_PRODUCT | Participants receive fibres and caloric equilibrate diet during breakfast and lunch every day for 21 consecutive days and diagnostic and treatment of childhood infections Active detection and treatment of pathogens every month for 12 months |
| Chikenpox or Varicella vaccine (VARILRIX) | BIOLOGICAL | The active comparator vaccine, a Varicella vaccine (VARILRIX®) |
| Placebo | OTHER | About 30 children do not receive diet, nor active pathogen detection |
Inclusion Criteria: * Healthy children aged 1 to 12 years (inclusive) at the time of inclusion. * Willingness of parent or legal guardian to provide written informed consent prior to screening procedures. * Willingness of the relatives of the participant to provide written informed consent if they ...