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
NCT05047770 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2013
Last updated 2023-11-13
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
- Herpes Zoster
Interventions
- 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
-
1 booster dose of mRNA-1273 vaccine administered intramuscularly at Day 1 (all groups).
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
GSK Clinical Trials · GlaxoSmithKline
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-10-07
- Primary Completion
- 2022-08-29
- Completion
- 2022-08-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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