A phase 1/2 randomized study to evaluate the safety, tolerability, and immunogenicity of a modified RNA vaccine against influenza in healthy individuals
Abstract
This study will be divided into two substudies - Substudy A (SSA) and Substudy B (SSB)
Substudy A This is a Phase 1 randomized substudy to evaluate the safety and immunogenicity of monovalent influenza modRNA vaccine (mIRV) and bivalent influenza modRNA vaccine (bIRV) at various dose levels, and quadrivalent influenza modRNA vaccine (qIRV), in participants 65 to 85 years of age. Participants will receive at Vaccination 1 either:
* 1 of 4 dose levels of mIRV (either A or B Strain),
* 1 of 4 dose levels of bIRV (containing both A and B strains),
* qIRV (at 1 dose level), or
* A licensed quadrivalent influenza vaccine (QIV).
At approximately 8 weeks following Vaccination 1, participants will be unblinded and QIV (Vaccination 2) administered to participants not having previously received this at Vaccination 1. Additionally, participants who previously received QIV at Vaccination 1 will receive one of the following for Vaccination 2:
* mIRV encoding A strain at dose level 4, or
* mIRV encoding B strain at dose level 4.
Substudy B
This is a randomized substudy to evaluate the safety and immunogenicity of the following vaccination schedules in participants 65 to 85 years of age:
2-Visit Schedules
* 2 doses of qIRV (at a dose level 1), administered 21 days apart.
* 2 doses of licensed QIV, administered 21 days apart (as a control group)
* A dose of licensed QIV following by a dose of bIRV encoding 2 A strains at dose level combination 1 or 2, administered 21 days apart.
1-Visit…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 1,158 participants or records.
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