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
Condition: Herpes Zoster
MeSH terms: Influenza, Human; Herpes Zoster
Intervention: HZ/su; Flu D-QIV; mRNA-1273
Intervention description: 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.; 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.; 1 booster dose of mRNA-1273 vaccine administered intramuscularly at Day 1 (all groups).
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Masking description: Open-label study; participants randomly assigned to either the co-administration or sequential study group.
Enrollment: 2013.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: COVID-19; Shingles; Influenza; Booster vaccination; HZ/su vaccine; Recombinant Zoster vaccine; Flu D-QIV vaccine; mRNA-1273 vaccine; Safety; Immunogenicity

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 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.