drugset / Trial / NCT05047770
A Study on the Immune Response and Safety of the Shingles Vaccine and the Influenza Vaccine When Either is Given to Healthy Adults at the Same Time or Following a COVID-19 Booster Vaccine
RandomizedParallel-groupOpen-labelPrevention
Summary
The aim of this study was to evaluate the immune response and safety of both GlaxoSmithKline Biologicals SA's (GSK's) herpes zoster (HZ) subunit (su) vaccine in healthy adults 50 years of age (YOA) and older and quadrivalent seasonal influenza (Flu D-QIV) vaccine in healthy adults 18 YOA and older, when administered sequentially or co-administered with Moderna's mRNA-1273 booster vaccination against COVID-19.
Timeline
- Start
- 2021-10-07
- Primary completion
- 2022-08-29
- Completion
- 2022-08-31
Outcome
Met primary endpoint
paper Protocol-specified noninferiority criteria were met. PMID 37335963 ↗
paper and 0.98 (0.84-1.13) for anti-Spike antibodies, thus meeting the protocol-specified non-inferiority criteria. PMID 38513689 ↗
Publications
- Naficy A, Kuxhausen A, Seifert H, Hastie A, Leav B, Miller J, Anteyi K, Mwakingwe-Omari A. No immunological interference or concerns about safety when seasonal quadrivalent influenza vaccine is co-administered with a COVID-19 mRNA-1273 booster vaccine in adults: A randomized trial. Hum Vaccin Immunother. 2024 Dec 31;20(1):2327736. doi: 10.1080/21645515.2024.2327736. Epub 2024 Mar 21.
- de Oliveira Gomes J, Gagliardi AM, Andriolo BN, Torloni MR, Andriolo RB, Puga MEDS, Canteiro Cruz E. Vaccines for preventing herpes zoster in older adults. Cochrane Database Syst Rev. 2023 Oct 2;10(10):CD008858. doi: 10.1002/14651858.CD008858.pub5.
- Naficy A, Kuxhausen A, Pirrotta P, Leav B, Miller J, Anteyi K, Danier J, Breuer T, Mwakingwe-Omari A. No Immunological Interference or Safety Concerns When Adjuvanted Recombinant Zoster Vaccine Is Coadministered With a Coronavirus Disease 2019 mRNA-1273 Booster Vaccine in Adults Aged 50 Years and Older: A Randomized Trial. Clin Infect Dis. 2023 Nov 11;77(9):1238-1246. doi: 10.1093/cid/ciad361.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Flu D-QIV | Vaccine | — | Intramuscular |
| Subject | HZ/su | Unknown | — | Intramuscular |
| Subject | mRNA-1273 | Messenger RNA (mRNA) | 50 ug | Intramuscular |