Phase 3
N=1,534
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
Herpes Zoster
Bottom Line
View on ClinicalTrials.gov: NCT05047770 ↗Enrolled (actual)
1,534
Serious AEs
1.3%
Results posted
Nov 2023
Primary outcome: Primary: Anti-glycoprotein E (gE) Antibody Concentrations Expressed as Geometric Mean Concentrations (GMCs) in HZ/suSeq and HZ/suCoAd Groups, and Between-group Ratios — 47434.82; 47599.82 mIU/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- HZ/su (Biological); Flu D-QIV (Combination_product); mRNA-1273 (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anti-glycoprotein E (gE) Antibody Concentrations Expressed as Geometric Mean Concentrations (GMCs) in HZ/suSeq and HZ/suCoAd Groups, and Between-group Ratios |
47434.82; 47599.82 | — |
| PRIMARY Anti-S Protein Antibody Concentrations Expressed as GMCs in HZ/suSeq and HZ/suCoAd Groups, and Between-group Ratios |
618638.92; 567728.74 | — |
| PRIMARY Anti-hemagglutinin Inhibition (HI) Antibody Titers Expressed as Geometric Mean Titers (GMTs) Against the 4 Influenza Strains in Flu D-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, and Between-group Ratios |
598.62; 577.77; 268.32; 280.26; 48.00; 47.21 | — |
| PRIMARY Anti-S Protein Antibody Concentrations Expressed as GMCs in FluD-QIVSeq and FluD-QIVCoAd Groups, and Between-group Ratios |
482604.31; 494646.32 | — |
| SECONDARY Percentage of Participants Seroconverted for Anti-HI Antibodies Against the 4 Influenza Strains in Flu D-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, and Between-group Differences |
73.7; 73.1; 48.7; 50.0; 28.9; 28.8 | — |
| SECONDARY Percentage of Participants Seropositive for Anti-gE Antibodies in HZ/suSeq and HZ/suCoAd Groups |
96.9; 98.3; 100; 100 | — |
| SECONDARY Anti-gE Antibody Concentrations Expressed as GMCs in HZ/suSeq and HZ/suCoAd Groups |
1243.79; 1361.01; 47434.82; 47599.82 | — |
| SECONDARY Percentage of Participants With a Vaccine Response for Anti-gE in HZ/suSeq and HZ/suCoAd Groups |
96.9; 97.4 | — |
| SECONDARY Mean Geometric Increase (MGI) for Anti-gE in HZ/suSeq and HZ/suCoAd Groups |
38.14; 34.97 | — |
| SECONDARY Anti-S Protein Antibody Concentrations Expressed as GMCs in HZ/suSeq and HZ/suCoAd Groups |
33138.45; 34223.23; 618638.92; 567728.74 | — |
| SECONDARY Anti-S Protein Antibody Concentrations Expressed as GMCs in FluD-QIVSeq and FluD-QIVCoAd Groups |
32654.66; 33635.52; 482604.31; 494646.32 | — |
| SECONDARY Mean Geometric Increase (MGI) for Anti-S Protein in HZ/suSeq and HZ/suCoAd Groups |
18.67; 16.59 | — |
| SECONDARY Mean Geometric Increase (MGI) for Anti-S Protein in FluD-QIVSeq and FluD-QIVCoAd Groups |
14.78; 14.71 | — |
| SECONDARY Anti-HI Antibody Titers Expressed as GMTs Against the 4 Influenza Strains in Flu D-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups |
65.18; 61.86; 598.62; 577.77; 70.93; 66.30 | — |
| SECONDARY Percentage of Participants Seroprotected for Anti-HI Antibodies Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, Overall and by Age Category |
71.1; 69.3; 98.9; 98.5; 71.1; 69.0 | — |
| SECONDARY Percentage of Participants Seropositive for Anti-HI Antibodies Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups |
91.6; 89.8; 99.8; 99.8; 94.5; 92.6 | — |
| SECONDARY Mean Geometric Increase (MGI) for Anti-HI Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups |
9.20; 9.38; 3.78; 4.23; 2.68; 2.70 | — |
| SECONDARY Percentage of Participants Seroconverted for Anti-HI Antibodies Against the 4 Influenza Strains in FluD-QIV Vaccine in FluD-QIVSeq and FluD-QIVCoAd Groups, Overall and by Age Category |
73.7; 73.1; 48.7; 50.0; 28.9; 28.8 | — |
| SECONDARY Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Local Adverse Events (AEs) |
15.1; 15.4; 81.6; 80.9; 25.0; 22.1 | — |
| SECONDARY Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Local Adverse Events (AEs) |
20.0; 14.3; 77.8; 74.6; 13.9; 13.9 | — |
| SECONDARY Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Solicited Systemic Adverse Events (AEs) |
11.0; 12.4; 37.5; 40.8; 39.0; 40.1 | — |
| SECONDARY Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Solicited Systemic Adverse Events (AEs) |
10.5; 6.6; 30.8; 29.8; 33.1; 29.2 | — |
| SECONDARY Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Unsolicited Adverse Events (AEs) |
41.5; 46.1; 25.2; 15.1; 23.3; 25.0 | — |
| SECONDARY Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Unsolicited Adverse Events (AEs) |
43.1; 36.9; 27.3; 29.6; 36.9 | — |
| SECONDARY Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Unsolicited Adverse Events (AEs) |
41.5; 46.1; 25.2; 15.1; 23.3; 25.0 | — |
| SECONDARY Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Unsolicited Adverse Events (AEs) |
43.1; 36.9; 27.3; 29.6; 36.9 | — |
| SECONDARY Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Serious Adverse Events (SAEs) |
1.8; 2.2 | — |
| SECONDARY Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Serious Adverse Events (SAEs) |
1.8; 2.2 | — |
| SECONDARY Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Serious Adverse Events (SAEs) |
1.4; 0.4 | — |
| SECONDARY Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Serious Adverse Events (SAEs) |
1.4; 0.4 | — |
| SECONDARY Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Potential Immune Mediated Diseases (pIMDs) |
0.3; 0.3 | — |
| SECONDARY Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Potential Immune Mediated Diseases (pIMDs) |
0.3; 0.3 | — |
| SECONDARY Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Adverse Events of Special Interest (AESIs) |
1.1; 0.7 | — |
| SECONDARY Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Adverse Events of Special Interest (AESIs) |
1.1; 0.7 | — |
| SECONDARY Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Adverse Events of Special Interest (AESIs) |
0.0; 0.2 | — |
| SECONDARY Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Reporting Adverse Events of Special Interest (AESIs) |
0.0; 0.2 | — |
| SECONDARY Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Reporting Clinically Suspected HZ Episodes |
0.7; 0.0 | — |
| SECONDARY Percentage of Participants in HZ/suSeq and HZ/suCoAd Groups Meeting Case Definitions of COVID-19 |
4.4; 4.1; 2.2; 2.2; 0.7; 0.3 | — |
| SECONDARY Percentage of Participants in FluD-QIVSeq and FluD-QIVCoAd Groups Meeting Case Definitions of COVID-19 |
4.6; 3.2; 1.8; 2.0; 0.6; 0.6 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Participants who in the opinion of the investigator, can and who will comply with the requirements of the protocol (e.g., completion of the eDiaries, return for follow-up visits).
- Written informed consent obtained from the participant prior to performance of any study-specific procedure.
- Age at study entry:
- For HZ/su and mRNA-1273 booster cohort: A male or female aged 50 years or older at the time of randomization.
- For Flu D-QIV and mRNA-1273 booster cohort: A male or female aged 18 years or older at the time of enrollment.
- Healthy participants or medically stable patients as established by medical history and clinical examination at screening. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrolment.
- Participants who have a documented previous mRNA-1273 primary vaccination series completed (i.e., both doses) at least 6 months prior to first vaccination.
- Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, documented total hysterectomy, bilateral ovariectomy, or bilateral salpingectomy, or post-menopause.
- Female participants of childbearing potential may be enrolled in the study, if the participant:
- Has practiced effective contraception for 1 month prior to study intervention administration, and
- Has a negative pregnancy test on the day of study intervention administration, and
- Has agreed to continue effective contraception during the study until 2 months after completion of the study vaccination series.
Exclusion Criteria
Medical conditions
- Any clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study or might confound post-study intervention administration safety assessments (e.g., tattoos overlying either study intervention administration site).
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions, including a known history of severe allergic reaction (e.g., anaphylaxis) to any component of any of the study vaccines.
- Any history of Guillain-Barré syndrome.
- Any history of myocarditis or pericarditis.
- Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history or physical examination.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- Hypersensitivity to latex.
- For HZ/su and mRNA-1273 booster cohort: history of Herpes Zoster.
Prior/concomitant therapy
- Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study intervention(s) during the period beginning 30 days before the first dose of study intervention(s) (Day -29 to Day 1), or their planned use during the study period.
- Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before first dose and ending 30 days after the last dose of study intervention administration. However, for HZ/su and mRNA-1273 booster cohort: licensed pneumococcal vaccines and non-replicating vaccines (i.e., inactivated and subunit vaccines, including inactivated and subunit influenza vaccines, with or without adjuvant for seasonal or pandemic flu) may be administered up until 8 days prior to dose 1 of HZ/su and/or dose 2 of HZ/su and/or at least 14 days after any dose of HZ/su. For Flu D-QIV and mRNA-1273 booster cohort: licensed pneumococcal vaccines and non-replicating vaccines (i.e., inactivated and subunit vaccines, other than influenza vaccines) may be administered up until 8 days prior to dose 1 of Flu D-QIV and/or at least 30 days after any dose of Fl
Data sourced from ClinicalTrials.gov (NCT05047770). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.