drugset / Trial / NCT05479370
Immunogenicity Trial of 3 Influenza Vaccines
Phase 3
Completed
366 enrolled
Tan Tock Seng Hospital
A*Star · collabSanofi · collabUniversity of Melbourne · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This study is a prospective randomised trial of 3 influenza vaccine formulations with different manufacturing processes: 1) egg-grown (QIV-E); 2) cell-grown (QIV-C); and 3) recombinant protein (QIV-R). The main objective is to compare the antibody responses following influenza vaccination among these 3 vaccines to determine whether recombinant vaccines offer superior protection over standard egg or cell-based formulations. The attenuating effects of prior vaccination on vaccine immunogenicity will also be evaluated. Hypothesis: Vaccination with recombinant vaccine results in better antibody responses, particularly against A(H3N2) viruses, than either standard egg-grown vaccines or cell-grown vaccines.
Timeline
- Start
- 2022-09-29
- Primary completion
- 2023-04-14
- Completion
- 2024-02-06
Publications
- Background Gouma S, Zost SJ, Parkhouse K, Branche A, Topham DJ, Cobey S, Hensley SE. Comparison of Human H3N2 Antibody Responses Elicited by Egg-Based, Cell-Based, and Recombinant Protein-Based Influenza Vaccines During the 2017-2018 Season. Clin Infect Dis. 2020 Sep 12;71(6):1447-1453. doi: 10.1093/cid/ciz996.
- Background Wang W, Alvarado-Facundo E, Vassell R, Collins L, Colombo RE, Ganesan A, Geaney C, Hrncir D, Lalani T, Markelz AE, Maves RC, McClenathan B, Mende K, Richard SA, Schofield C, Seshadri S, Spooner C, Utz GC, Warkentien TE, Levine M, Coles CL, Burgess TH, Eichelberger M, Weiss CD. Comparison of A(H3N2) Neutralizing Antibody Responses Elicited by 2018-2019 Season Quadrivalent Influenza Vaccines Derived from Eggs, Cells, and Recombinant Hemagglutinin. Clin Infect Dis. 2021 Dec 6;73(11):e4312-e4320. doi: 10.1093/cid/ciaa1352.
- Sullivan SG, Poh XY, Sanchez-Ovando S, Hadiprodjo AJ, Carolan L, Chin YQ, Rao S, Sutjipto S, Lim J, Anthony D, Sadarangani SP, Barr IG, Young B, Fox A. Immunogenicity of high-dose recombinant influenza vaccine versus standard-dose egg-grown and cell-grown vaccines among frequently and infrequently vaccinated young adults in Singapore: a randomised, controlled, double-blind, single-centre, phase 4 clinical trial. Lancet Infect Dis. 2026 Apr 2:S1473-3099(26)00062-9. doi: 10.1016/S1473-3099(26)00062-9. Online ahead of print.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Flublok | Vaccine | 0.5 ml | Intramuscular |
| Subject | Flucelvax | Vaccine | 0.5 ml | Intramuscular |
| Subject | Influenza Virus Vaccine | Vaccine | 0.5 ml | Intramuscular |
Indications
No indication recorded.