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Vaccine

HZ/su for Shingles

Phase 3
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 month post-flu d-qiv vaccine dose administration (week 6 for flud-qivseq group and week 4 for flud-qivcoad group) compared to pre-vaccination (week 2 for flud-qivseq group and day 1 for flud-qivcoad group)
Awards & highlights

Study Summary

This study is evaluating whether a vaccine against HZ and Flu can be safely administered together or separately.

Eligible Conditions
  • Shingles

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at pre-vaccination (day 1) and at 1 month post-mrna-1273 booster dose administration (week 4 for both hz/suseq and hz/sucoad groups)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at pre-vaccination (day 1) and at 1 month post-mrna-1273 booster dose administration (week 4 for both hz/suseq and hz/sucoad groups) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Anti-S Protein Antibody Concentrations Expressed as GMCs in FluD-QIVSeq and FluD-QIVCoAd Groups, and Between-group Ratios
Anti-S Protein Antibody Concentrations Expressed as GMCs in HZ/suSeq and HZ/suCoAd Groups, and Between-group Ratios
Anti-glycoprotein E (gE) Antibody Concentrations Expressed as Geometric Mean Concentrations (GMCs) in HZ/suSeq and HZ/suCoAd Groups, and Between-group Ratios
+1 more
Secondary outcome measures
Anti-HI Antibody Titers Expressed as GMTs Against the 4 Influenza Strains in Flu D-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups
Anti-S Protein Antibody Concentrations Expressed as GMCs in FluD-QIVSeq and FluD-QIVCoAd Groups
Anti-S Protein Antibody Concentrations Expressed as GMCs in HZ/suSeq and HZ/suCoAd Groups
+25 more

Side effects data

From 2022 Phase 3 trial • 2013 Patients • NCT05047770
82%
Injection site pain
67%
Myalgia
58%
Fatigue
52%
Headache
43%
Chills
42%
Arthralgia
25%
Injection site pruritus
25%
Diarrhoea
23%
Nausea
18%
Injection site erythema
15%
Lymphadenopathy
14%
Abdominal pain
11%
Pyrexia
9%
Injection site swelling
4%
Vomiting
2%
Upper respiratory tract infection
1%
Sneezing
1%
Urinary tract infection
1%
Nasopharyngitis
1%
Constipation
1%
Fall
1%
Dermatitis contact
1%
Nephrolithiasis
1%
COVID-19
100%
80%
60%
40%
20%
0%
Study treatment Arm
HZ/suSeq Group
HZ/suCoAd Group
FluD-QIVSeq Group
FluD-QIVCoAd Group

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: HZ/suCoAd GroupExperimental Treatment2 Interventions
Participants randomized to HZ/suCoAd Group received one mRNA-1273 booster dose co-administered with the first dose of HZ/su vaccine at Day 1, followed by the second dose of HZ/su vaccine administered at Week 8.
Group II: FluD-QIVCoAd GroupExperimental Treatment2 Interventions
Participants randomized to FluD-QIVCoAd Group received one mRNA-1273 booster dose co-administered with one dose of Flu D-QIV vaccine at Day 1.
Group III: HZ/suSeq GroupActive Control2 Interventions
Participants randomized to HZ/suSeq Group received one mRNA-1273 booster dose administered at Day 1, followed by the first dose of HZ/su vaccine administered at Week 2 and the second dose of HZ/su vaccine administered at Week 10.
Group IV: FluD-QIVSeq GroupActive Control2 Interventions
Participants randomized to FluD-QIVSeq Group received one mRNA-1273 booster dose at Day 1, followed by one dose of Flu D-QIV vaccine at Week 2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mRNA-1273
2021
Completed Phase 4
~58700
Flu D-QIV
2021
Completed Phase 3
~2020
HZ/su
2021
Completed Phase 3
~2310

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,751 Previous Clinical Trials
8,065,459 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,141,917 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
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
2021. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05047770.
~575 spots leftby Apr 2025
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