What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Inactivated influenza vaccine (IIV) at baseline, COVID-19 Vaccines at a 3-month interval, or Inactivated influenza vaccine at Month 1. The registry lists allocation as randomized. The goal of this pragmatic embedded open-label, 2 x 2 factorial phase II randomly assigned controlled trial is to evaluate strategies to improve COVID-19 booster and influenza vaccine immunogenicity in people living with immunocompromising conditions (PLIC).
They plan to enroll about 660 people at 3 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.
Official title (unrewritten)
The Immunogenicity and Safety of COVID-19 and Influenza Vaccine Co-administration and Interval in Immunocompromised Hosts
Interventions: Inactivated influenza vaccine (IIV) at baseline, COVID-19 Vaccines at a 3-month interval, Inactivated influenza vaccine at Month 1, COVID-19 Vaccines at a 6-month interval
Primary outcome (registry wording): Median neutralization capacity against prevalent SARS-CoV-2 variant
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- \- All participants must meet ALL the following who can join: i. Adults (≥18 years) ii. Received the primary mRNA COVID-19 vaccine series (i.e., ≥3 doses) iii. Have at least one of the following immunocompromising conditions:
Who the registry excludes
- Potential participants who meet ANY of the following criteria will be excluded:
- i. Received any of the following:
- Annual vaccination against influenza \< 6 months ago
- COVID-19 booster \< 3 months ago ii. History of any of the following:
- life-threatening reaction any component of the IIV or COVID-19 vaccines
- Guillain-Barre syndrome or myocarditis within 6 weeks of a previous influenza or COVID-19 vaccination