Trials / Completed
CompletedNCT05047770
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
A Phase III, Randomized, Open-label, Controlled, Multicenter Study to Evaluate the Immune Response and Safety of Both Herpes Zoster Subunit Vaccine in Healthy Adults Aged 50 Years and Older AND the Influenza Virus Vaccine in Healthy Adults Aged 18 Years and Older When Administered Sequentially or Coadministered With mRNA-1273 Booster Vaccination
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 2,013 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | HZ/su | 2 doses of HZ/su vaccine administered intramuscularly, either sequentially (HZ/suSeq Group) or simultaneously (HZ/suCoAd Group) with the mRNA-1273 booster dose. The second dose of HZ/su was administered 8 weeks after the first dose of HZ/su vaccine. |
| COMBINATION_PRODUCT | Flu D-QIV | 1 dose of Flu D-QIV vaccine administered intramuscularly, either sequentially (FluD-QIVSeq Group) or simultaneously (FluD-QIVCoAd Group) with the mRNA-1273 booster dose. |
| BIOLOGICAL | mRNA-1273 | 1 booster dose of mRNA-1273 vaccine administered intramuscularly at Day 1 (all groups). |
Timeline
- Start date
- 2021-10-07
- Primary completion
- 2022-08-29
- Completion
- 2022-08-31
- First posted
- 2021-09-17
- Last updated
- 2023-11-13
- Results posted
- 2023-11-13
Locations
46 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05047770. Inclusion in this directory is not an endorsement.