The Celljuvant Study
Research type
Research Study
Full title
A Phase 3, Randomized, Observer-Blind, Controlled, Multicenter, Clinical Study to Evaluate Immunogenicity and Safety of a HighDose MF59-Adjuvanted Quadrivalent Subunit Cell-derived Influenza Vaccine (aQIVc HD) in Comparison with a Non-adjuvanted Quadrivalent Recombinant Influenza Vaccine (QIVr) and an MF59-Adjuvanted Quadrivalent Subunit Egg-derived Influenza Vaccine (aQIV), in Adults Aged 50 Years and Older.
IRAS ID
1007960
Contact name
Renate Verbeeten-van Hoof
Contact email
Sponsor organisation
Seqirus UK Limited
Clinicaltrials.gov Identifier
Research summary
Summary of Research
This is a phase 3 (this means that it has already been tested on a smaller group of patients before) multicentre study being conducted by Seqirus UK Ltd. This study will test an investigational vaccine named aQIVc HD. This study is being conducted to learn more about the response in terms of immunity and possible side effects that the investigational vaccine has on adults 50 years of age and older.
The study will have two groups, a control group (standard treatment) and investigational group. The control group will receive any of the 2 comparators (Fluad Tetra or Flublok Quadrivalent /Supemtek). The investigational vaccine group will receive aQIVc HD.
The route of administration for the vaccines will be intramuscular (into a muscle). The total study duration is 6 months after vaccination (day 1). In total, the participant will visit the study site 2 times, and there will be a remote contact (phone call) with the participants at 3 months and 6 months after the last study intervention.
During the study, participants will have the following procedures (but not limited to): physical examinations, blood sampling, pregnancy testing, and questionnaires. The participants will be required to complete an electronic diary, for which they will receive training.
Approximately, 7700 participants will take part in this world-wide study, including 300 participants in the UK (at private sites). All participants will be over 50 years old. The study is observer blind. This means that neither the person getting the vaccine, nor the study doctor will know which study vaccine is given. Only the person who will give the injection will know which vaccine was given. However, the study doctor will be able to find out this information if needed in an emergency.
Summary of Results
In this study, the researchers wanted to learn more about a new flu vaccine, a higher dose MF59-adjuvanted quadrivalent subunit cell-derived influenza vaccine (aQIVc HD). Participants were randomly assigned to receive a single dose of aQIVc HD or 1 of 2 currently available flu vaccines called QIVr (recombinant) and aQIV (MF59-adjuvanted egg-derived). The participants were 50 to 95 years old when they agreed to take part in the study. The researchers compared the participants’ immune responses to the 3 vaccines one month after receiving the dose. To measure the participants’ immune responses, the study researchers measured the levels of antibodies for the 4 different flu virus strains contained in the study vaccines. The researchers found that different batches of the aQIVc HD vaccine produced similar levels of antibodies. In addition, they found that the aQIVc HD vaccine caused a similar or stronger immune response compared to the QIVr vaccine for 3 of the 4 flu strains tested, and that the aQIVc HD vaccine caused a similar or stronger immune response compared to the aQIV vaccine for all 4 of the flu strains. Participants receiving aQIVc HD reported local and systemic reactions that were mostly mild or moderate in intensity and lasted for 1 or 2 days. Overall, 0.9% of participants (72 out of 7,677) had an adverse event that could have been related to their study vaccine in the 4 weeks after receiving their dose.
REC name
London - Fulham Research Ethics Committee
REC reference
23/LO/0619
Date of REC Opinion
8 Nov 2023
REC opinion
Further Information Favourable Opinion