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

The aim of this study is 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 Overview

• Status: Completed
• Conditions: Herpes Zoster
• Intervention / Treatment: Biological: HZ/su; Biological: mRNA-1273; Combination product: Flu D-QIV

• Study Type: Interventional
• Enrollment (Actual): 2450
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85283
      • GSK Investigational Site
  • California
    • Oxnard, California, United States, 93030-5841
      • GSK Investigational Site
    • San Diego, California, United States, 92103
      • GSK Investigational Site
    • San Diego, California, United States, 92103-6204
      • GSK Investigational Site
  • Florida
    • Atlantis, Florida, United States, 33462
      • GSK Investigational Site
    • Fort Myers, Florida, United States, 33912
      • GSK Investigational Site
    • Jacksonville, Florida, United States, 32256
      • GSK Investigational Site
    • Lake Worth, Florida, United States, 33461
      • GSK Investigational Site
    • Miami, Florida, United States, 33143
      • GSK Investigational Site
    • Miami, Florida, United States, 33173
      • GSK Investigational Site
    • Miami, Florida, United States, 33135
      • GSK Investigational Site
    • Ocala, Florida, United States, 34471
      • GSK Investigational Site
    • Orlando, Florida, United States, 32801
      • GSK Investigational Site
    • Sarasota, Florida, United States, 34243-2878
      • GSK Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • GSK Investigational Site
    • Columbus, Georgia, United States, 31904
      • GSK Investigational Site
  • Idaho
    • Meridian, Idaho, United States, 83642
      • GSK Investigational Site
  • Kansas
    • El Dorado, Kansas, United States, 67042
      • GSK Investigational Site
    • Newton, Kansas, United States, 67114
      • GSK Investigational Site
    • Topeka, Kansas, United States, 66606
      • GSK Investigational Site
    • Wichita, Kansas, United States, 67207
      • GSK Investigational Site
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • GSK Investigational Site
  • Mississippi
    • Biloxi, Mississippi, United States, 39531
      • GSK Investigational Site
  • Nebraska
    • Fremont, Nebraska, United States, 68025-2592
      • GSK Investigational Site
    • Omaha, Nebraska, United States, 68114
      • GSK Investigational Site
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • GSK Investigational Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • GSK Investigational Site
  • Ohio
    • Columbus, Ohio, United States, 43213
      • GSK Investigational Site
  • Oklahoma
    • Norman, Oklahoma, United States, 73072
      • GSK Investigational Site
    • Oklahoma City, Oklahoma, United States, 73112
      • GSK Investigational Site
    • Yukon, Oklahoma, United States, 73099
      • GSK Investigational Site
  • Oregon
    • Grants Pass, Oregon, United States, 97527
      • GSK Investigational Site
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • GSK Investigational Site
    • Columbia, South Carolina, United States, 29204
      • GSK Investigational Site
    • Greenville, South Carolina, United States, 29615
      • GSK Investigational Site
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • GSK Investigational Site
  • Texas
    • Beaumont, Texas, United States, 77706
      • GSK Investigational Site
    • Cedar Park, Texas, United States, 78613
      • GSK Investigational Site
    • Houston, Texas, United States, 77090
      • GSK Investigational Site
    • San Antonio, Texas, United States, 78229
      • GSK Investigational Site
    • Tomball, Texas, United States, 77375
      • GSK Investigational Site
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • GSK Investigational Site
    • West Jordan, Utah, United States, 84088
      • GSK Investigational Site
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • GSK Investigational Site
  • Washington
    • Cheney, Washington, United States, 99204
      • GSK Investigational Site
    • Tacoma, Washington, United States, 98405
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Flu D-QIV. For time interval between other routine vaccines with mRNA-1273 booster dose (administered in the study), local guidelines must be followed.

In case emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is organized by public health authorities outside the routine immunization program, the time period described above can be reduced if necessary for that mass vaccination vaccine, provided this vaccine is licensed and used according to its Product Information.

• Administration of long-acting immune-modifying drugs at any time during the study period (e.g., infliximab).
• Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the first dose of study intervention(s) up to 1 month post last dose or planned administration during the study period.
• Prior planned or chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first vaccine. For corticosteroids, this will mean more than 14 days in total of prednisone ≥20 mg/day or equivalent is not allowed. Inhaled, intra-articular and topical steroids are allowed.
• For HZ/su and mRNA-1273 booster cohort: Previous vaccination against Herpes Zoster with the exception of receipt of live attenuated HZ vaccine.
• For Flu D-QIV and mRNA-1273 booster cohort: Administration of a seasonal influenza vaccine during the 6 months preceding entry into the study.
• Prior administration of an investigational or licensed coronavirus (SARS-CoV, MERS-CoV, SARS-CoV-2) vaccine except for mRNA-1273 vaccine.
• Any contraindication to the study intervention(s).

Prior/concurrent clinical study experience

• Planning to or concurrently participating in another clinical study (including current / planned simultaneous participation in another interventional study to prevent or treat COVID-19), at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine / product (drug or medical device).

Other exclusions

• Pregnant or lactating female.
• Female planning to become pregnant or planning to discontinue contraceptive precautions within 2 months following last study vaccination.
• Indications of drug abuse or excess alcohol use as deemed by investigator to potentially confound safety assessments or render participant unable or unlikely to adhere to protocol requirements.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: HZ/suSeq Group; Participants randomized to HZ/suSeq Group receive 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.	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 is administered 8 weeks after the first dose of HZ/su vaccine.; Biological: mRNA-1273; 1 booster dose of mRNA-1273 vaccine administered intramuscularly at Day 1 (all groups).
Experimental: HZ/suCoAd Group; Participants randomized to HZ/suCoAd Group receive 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.	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 is administered 8 weeks after the first dose of HZ/su vaccine.; Biological: mRNA-1273; 1 booster dose of mRNA-1273 vaccine administered intramuscularly at Day 1 (all groups).
Active Comparator: FluD-QIVSeq Group; Participants randomized to FluD-QIVSeq Group receive one mRNA-1273 booster dose at Day 1, followed by one dose of Flu D-QIV vaccine at Week 2.	Biological: mRNA-1273; 1 booster dose of mRNA-1273 vaccine administered intramuscularly at Day 1 (all groups).; 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.; Other Names: Flu Quadrivalent Influenza Vaccine
Experimental: FluD-QIVCoAd Group; Participants randomized to FluD-QIVCoAd Group receive one mRNA-1273 booster dose co-administered with one dose of Flu D-QIV vaccine at Day 1.	Biological: mRNA-1273; 1 booster dose of mRNA-1273 vaccine administered intramuscularly at Day 1 (all groups).; 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.; Other Names: Flu Quadrivalent Influenza Vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti-glycoprotein E (gE) antibody concentrations expressed as Geometric Mean Concentrations (GMCs) in HZ/suSeq and HZ/suCoAd groups, and between-group ratios		At 1 month post-dose 2 of HZ/su vaccine administration (Week 14 for HZ/suSeq group and Week 12 for HZ/suCoAd group)
Anti-S protein antibody concentrations expressed as GMCs in HZ/suSeq and HZ/suCoAd groups, and between-group ratios		At 1 month post-mRNA-1273 booster dose administration (Week 4)
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	The 4 influenza strains assessed are A/H1N1 strain, A/H3N2 strain, B/Victoria lineage and B/Yamagata lineage.	At 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluDQIVSeq group and Week 4 for FluDQIVCoAd group)
Anti-S protein antibody concentrations expressed as GMCs in FluD-QIVSeq and FluD-QIVCoAd groups, and between-group ratios		At 1 month post-mRNA-1273 booster dose administration (Week 4)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants seroconverted for anti-HI antibodies against the 4 influenza strains in FluD-QIVSeq and FluD-QIVCoAd groups, and between-group differences	A participant seroconverted for anti-HI antibodies against the 4 influenza strains is defined as a participant having either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4 fold increase in post-vaccination titer. The 4 influenza strains assessed are A/H1N1 strain, A/H3N2 strain, B/Victoria lineage and B/Yamagata lineage.	At 1 month post Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group)
Percentage of participants seropositive for anti-gE antibodies in HZ/suSeq and HZ/suCoAd groups	A participant seropositive for anti-gE antibodies is defined as a participant whose antibody concentration is greater than or equal to the assay cut-off value (97 mIU/mL).	At pre-vaccination (Week 2 for HZ/suSeq group and Day 1 for HZ/suCoAd group) and at 1 month post-dose 2 of HZ/su vaccine administration (Week 14 for HZ/suSeq group and Week 12 for HZ/suCoAd group)
Anti-gE antibody concentrations expressed as GMCs in HZ/suSeq and HZ/suCoAd groups		At pre-vaccination (Week 2 for HZ/suSeq group and Day 1 for HZ/suCoAd group) and at 1 month post-dose 2 of HZ/su vaccine administration (Week 14 for HZ/suSeq group and Week 12 for HZ/suCoAd group)
Percentage of participants with a vaccine response for anti-gE in HZ/suSeq and HZ/suCoAd groups	A participant with vaccine response for anti-gE is defined as a participant with: A 4-fold increase in the post-dose anti-gE antibodies concentration as compared to the pre-vaccination anti-gE antibodies concentration, for participants who are seropositive at pre-vaccination, or, A 4-fold increase in the post-dose anti-gE antibodies concentration as compared to the anti-gE antibodies cut-off value for seropositivity, for participants who are seronegative at pre-vaccination.	At 1 month post-dose 2 of HZ/su vaccine administration (Week 14 for HZ/suSeq group and Week 12 for HZ/suCoAd group)
Mean geometric increase (MGI) for anti-gE in HZ/suSeq and HZ/suCoAd groups	MGI is defined as the geometric mean of the within participant ratios of the post-vaccination anti-gE antibody concentration to the Day 1 anti-gE antibody concentration.	At 1 month post-dose 2 of HZ/su vaccine administration (Week 14 for HZ/suSeq group and Week 12 for HZ/suCoAd group) compared to pre-vaccination (Week 2 for HZ/suSeq group and Day 1 for HZ/suCoAd group)
Anti-S protein antibody concentrations expressed as GMCs in HZ/suSeq and HZ/suCoAd groups		At pre-vaccination (Day 1) and at 1 month post-mRNA-1273 booster dose administration (Week 4)
Anti-S protein antibody concentrations expressed as GMCs in FluD-QIVSeq and FluD-QIVCoAd groups		At pre-vaccination (Day 1) and at 1 month post-mRNA-1273 booster dose administration (Week 4)
MGI for anti-S protein in HZ/suSeq and HZ/suCoAd groups	MGI is defined as the geometric mean of the within participant ratios of the post-vaccination anti-S protein antibody concentration to the Day 1 anti-S protein antibody concentration.	At 1 month post-mRNA-1273 booster dose administration (Week 4) compared to pre-vaccination (Day 1)
MGI for anti-S protein in FluD-QIVSeq and FluD-QIVCoAd groups	MGI is defined as the geometric mean of the within participant ratios of the post-vaccination anti-S protein antibody concentration to the Day 1 anti-S protein antibody concentration.	At 1 month post-mRNA-1273 booster dose administration (Week 4) compared to pre-vaccination (Day 1)
Anti-HI antibody titers expressed as GMTs against the 4 influenza strains in Flu D-QIV vaccine in FluD-QIVSeq and FluD-QIVCoAd groups	The 4 influenza strains assessed are A/H1N1 strain, A/H3N2 strain, B/Victoria lineage and B/Yamagata lineage.	At pre-vaccination (Week 2 for FluD-QIVSeq group and Day 1 for FluD-QIVCoAd group) and at 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group)
Percentage of participants seroprotected for anti-HI against the 4 influenza strains in FluD-QIVSeq and FluD-QIVCoAd groups	A participant seroprotected for anti-HI against the 4 influenza strains is defined as a participant with a serum HI titer ≥ 1:40. The 4 influenza strains assessed are A/H1N1 strain, A/H3N2 strain, B/Victoria lineage and B/Yamagata lineage.	At pre-vaccination (Week 2 for FluD-QIVSeq group and Day 1 for FluD-QIVCoAd group) and at 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group)
Percentage of participants seropositive for anti-HI against the 4 influenza strains in FluD-QIVSeq and FluD-QIVCoAd groups	A participant seropositive for anti-HI against the 4 influenza strains is defined as a participant with a serum HI titer ≥ 1:10. The 4 influenza strains assessed are A/H1N1 strain, A/H3N2 strain, B/Victoria lineage and B/Yamagata lineage.	At pre-vaccination (Week 2 for FluD-QIVSeq group and Day 1 for FluD-QIVCoAd group) and at 1 month post-Flu D-QIV vaccine dose administration (Week 6 for FluD-QIVSeq group and Week 4 for FluD-QIVCoAd group)
MGI for anti-HI against the 4 influenza strains in FluD-QIVSeq and FluD-QIVCoAd groups	MGI is defined as the geometric mean of the within participant ratios of the post-vaccination reciprocal HI titer to the Day 1 reciprocal HI titer. The 4 influenza strains assessed are A/H1N1 strain, A/H3N2 strain, B/Victoria lineage and B/Yamagata lineage.	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)
Percentage of participants seroconverted for anti-HI against the 4 influenza strains in FluD-QIVSeq and FluD-QIVCoAd groups, per age strata	A participant seroconverted for anti-HI antibodies against the 4 influenza strains is defined as a participant having either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4 fold increase in post-vaccination titer. The age strata assessed are 18-64 and ≥ 65 years of age. The 4 influenza strains assessed are A/H1N1 strain, A/H3N2 strain, B/Victoria lineage and B/Yamagata lineage.	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)
Percentage of participants in HZ/suSeq and HZ/suCoAd groups reporting solicited local adverse events	The assessed solicited local adverse events include pain, redness, swelling, and pruritus (for HZ/su vaccination only) at the administration site, and axillary (underarm) swelling or tenderness ipsilateral to the site of mRNA-1273 booster vaccination.	Within 7 days after each vaccine dose and across doses (vaccines administered at Day 1, Week 2 and Week 10 for HZ/suSeq group and at Day 1 and Week 8 for HZ/suCoAd group)
Percentage of participants in FluD-QIVSeq and FluD-QIVCoAd groups reporting solicited local adverse events	The assessed solicited local adverse events include pain, redness, and swelling at the administration site, and axillary (underarm) swelling or tenderness ipsilateral to the site of mRNA-1273 booster vaccination.	Within 7 days after each vaccine dose and across doses (vaccines administered at Day 1 and Week 2 for FluD-QIVSeq group and at Day 1 for FluD-QIVCoAd group)
Percentage of participants in HZ/suSeq and HZ/suCoAd groups reporting solicited systemic adverse events	The assessed solicited systemic adverse events include fatigue, myalgia, headache, shivering/chills, fever, gastrointestinal symptoms (nausea, vomiting, diarrhea and/or abdominal pain) and arthralgia. Fever is defined as temperature ≥ 38.0°C (100.4°F) by any route. The preferred location for measuring temperature is the oral route.	Within 7 days after each vaccine dose and across doses (vaccines administered at Day 1, Week 2 and Week 10 for HZ/suSeq group and at Day 1 and Week 8 for HZ/suCoAd group)
Percentage of participants in FluD-QIVSeq and FluD-QIVCoAd groups reporting solicited systemic adverse events	The assessed solicited systemic adverse events include fatigue, myalgia, headache, shivering/chills, fever, gastrointestinal symptoms (nausea, vomiting, diarrhea and/or abdominal pain) and arthralgia. Fever is defined as temperature ≥ 38.0°C (100.4°F) by any route. The preferred location for measuring temperature is the oral route.	Within 7 days after each vaccine dose and across doses (vaccines administered at Day 1 and Week 2 for FluD-QIVSeq group and at Day 1 for FluD-QIVCoAd group)
Percentage of participants in HZ/suSeq and HZ/suCoAd groups reporting unsolicited adverse events	An unsolicited AE is an AE that was either not included in the list of solicited events using a Participant Diary or could be included in the list of solicited events but with an onset more than 7 days following administration of a study intervention.	Within 14 days after each vaccine dose and across doses (vaccines administered at Day 1, Week 2 and Week 10 for HZ/suSeq group and at Day 1 and Week 8 for HZ/suCoAd group)
Percentage of participants in FluD-QIVSeq and FluD-QIVCoAd groups reporting unsolicited adverse events	An unsolicited AE is an AE that was either not included in the list of solicited events using a Participant Diary or could be included in the list of solicited events but with an onset more than 7 days following administration of a study intervention.	Within 14 days after each vaccine dose and across doses (vaccines administered at Day 1 and Week 2 for FluD-QIVSeq group and at Day 1 for FluD-QIVCoAd group)
Percentage of participants in HZ/suSeq and HZ/suCoAd groups reporting unsolicited adverse events	An unsolicited AE is an AE that was either not included in the list of solicited events using a Participant Diary or could be included in the list of solicited events but with an onset more than 7 days following administration of a study intervention.	Within 30 days after each vaccine dose and across vaccine doses (vaccines administered at Day 1, Week 2 and Week 10 for HZ/suSeq group and at Day 1 and Week 8 for HZ/suCoAd group)
Percentage of participants in FluD-QIVSeq and FluD-QIVCoAd groups reporting unsolicited adverse events	An unsolicited AE is an AE that was either not included in the list of solicited events using a Participant Diary or could be included in the list of solicited events but with an onset more than 7 days following administration of a study intervention.	Within 30 days after each vaccine dose and across vaccine doses (vaccines administered at Day 1 and Week 2 for FluD-QIVSeq group and at Day 1 for FluD-QIVCoAd group)
Percentage of participants reporting serious adverse events (SAEs)	An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is considered or defined as an important medical event, or abnormal pregnancy outcomes.	From first vaccine dose (Day 1) up to 30 days post-last vaccine dose within each group
Percentage of participants reporting SAEs	An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is considered or defined as an important medical event, or abnormal pregnancy outcomes.	From first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose)
Percentage of participants in HZ/suSeq and HZ/suCoAd groups reporting potential immune mediated diseases (pIMDs)	pIMDs include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.	From first vaccine dose (Day 1) up to 30 days post-last vaccine dose within each group
Percentage of participants in HZ/suSeq and HZ/suCoAd groups reporting pIMDs	pIMDs include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.	From first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose)
Percentage of participants reporting adverse events of special interest (AESIs)	AESIs are medical concepts that may be related to COVID-19 or are of interest in COVID-19 vaccine safety surveillance.	From first vaccine dose (Day 1) up to 30 days post-last vaccine dose within each group
Percentage of participants reporting AESIs	AESIs are medical concepts that may be related to COVID-19 or are of interest in COVID-19 vaccine safety surveillance.	From first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose)
Percentage of participants in HZ/suSeq and HZ/suCoAd groups reporting clinically suspected HZ episodes		From first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose)
Percentage of participants meeting case definitions of COVID-19	Primary Case Definition: Experienced at least TWO of following systemic symptoms: fever (temperature ≥38ºC), chills, myalgia, headache, sore throat, new olfactory & taste disorder(s), OR at least ONE of following respiratory signs: cough, shortness of breath or difficulty breathing, OR clinical or radiographical evidence of pneumonia; AND must have at least one nasopharyngeal (NP) or nasal swab, or saliva or respiratory sample positive for SARS-CoV-2 by PCR. Secondary Case Definition: Following systemic symptoms: fever, or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle aches or body aches, headache, new loss of taste or smell, sore throat, nasal congestion or rhinorrhea, nausea or vomiting, or diarrhea AND a positive NP or nasal swab, or saliva or respiratory sample for SARS-CoV-2 by PCR. Tertiary Case Definition: Documented COVID-19 diagnosis made by health care provider and not meeting the above case definitions.	From first vaccine dose (Day 1) up to study end (24 weeks post-last vaccine dose)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2021
• Primary Completion (Actual): August 29, 2022
• Study Completion (Actual): August 29, 2022

Study Registration Dates

• First Submitted: September 15, 2021
• First Submitted That Met QC Criteria: September 15, 2021
• First Posted (Actual): September 17, 2021

Study Record Updates

• Last Update Posted (Estimate): December 7, 2022
• Last Update Submitted That Met QC Criteria: December 6, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Safety; Influenza; COVID-19; Immunogenicity; Shingles; Booster vaccination; HZ/su vaccine; Recombinant Zoster vaccine; Flu D-QIV vaccine; mRNA-1273 vaccine
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; DNA Virus Infections; Orthomyxoviridae Infections; Herpesviridae Infections; Varicella Zoster Virus Infection; Influenza, Human; Herpes Zoster; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: 217670

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
• IPD Sharing Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
• IPD Sharing Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No