A Study on the Immune Response and Safety of a Combined Measles, Mumps, Rubella, Chickenpox Vaccine Compared to a Marketed Combined Vaccine, Given to Healthy Children 4 to 6 Years of Age
Condition: Measles; Mumps; Rubella; Chickenpox Interventions: Biological: Investigational MMRV(H)NS vaccine; Biological: Investigational MM(H)RVNS vaccine; Biological: Investigational M(L)M(L)R(L)V(L)NS vaccine; Biological: Marketed MMRV_Lot 1 and Lot 2 vaccine Sponsor: GlaxoSmithKline Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - November 30, 2022 Category: Research Source Type: clinical trials
Study protocol for a phase 1/2, single-centre, double-blind, double-dummy, randomized, active-controlled, age de-escalation trial to assess the safety, tolerability and immunogenicity of a measles and rubella vaccine delivered by a microneedle patch in healthy adults (18 to 40 years), measles and rubella vaccine-primed toddlers (15 to 18 months) and measles and rubella vaccine-na ïve infants (9 to 10 months) in The Gambia [Measles and Rubella Vaccine Microneedle Patch Phase 1/2 Age De-escalation Trial]
DiscussionThis trial will provide the first clinical data on the use of a MNP to deliver the MRV and the first data on the use of MNPs in a paediatric population. It will guide future product development decisions for what may be a key technology for future measles and rubella elimination.Trial registrationPan-African Clinical Trials Registry202008836432905.ClinicalTrials.govNCT04394689 (Source: Trials)
Source: Trials - September 14, 2022 Category: Research Source Type: clinical trials
