CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,013 enrolled
Drug / intervention
HZ/su +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05047770
NCT05047770Phase 3Completed
CompareCT.gov

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

GlaxoSmithKline·interventional·Posted Sep 17, 2021·Updated Nov 13, 2023

In Brief

A Phase 3 clinical trial evaluating HZ/su, Flu D-QIV, and 1 other intervention for Herpes Zoster. Completed, enrolled 2,013 participants across 46 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHerpes Zoster
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedSep 17, 2021
Enrollment StartOct 7, 2021
Primary CompletionAug 29, 2022
Study CompletionAug 31, 2022
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 4.8 years ago

Interventions

HZ/subiological

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.

Flu D-QIVcombination

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.

mRNA-1273biological

1 booster dose of mRNA-1273 vaccine administered intramuscularly at Day 1 (all groups).