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

Last updated: October 19, 2023
Sponsor: GlaxoSmithKline
Overall Status: Completed

Phase

3

Condition

Chickenpox (Varicella Zoster Infection)

Herpes Simplex Infections

Shingles

Treatment

mRNA-1273

Flu D-QIV

HZ/su

Clinical Study ID

NCT05047770
217670
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion Criteria:

  • Participants who in the opinion of the investigator, can and who will comply with therequirements of the protocol (e.g., completion of the eDiaries, return for follow-upvisits).
  • Written informed consent obtained from the participant prior to performance of anystudy-specific procedure.
  • Age at study entry:
  • For HZ/su and mRNA-1273 booster cohort: A male or female aged 50 years or olderat the time of randomization.
  • For Flu D-QIV and mRNA-1273 booster cohort: A male or female aged 18 years orolder at the time of enrollment.
  • Healthy participants or medically stable patients as established by medical historyand clinical examination at screening. A stable medical condition is defined asdisease not requiring significant change in therapy or hospitalization for worseningdisease during the 3 months before enrolment.
  • Participants who have a documented previous mRNA-1273 primary vaccination seriescompleted (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 tuballigation or occlusion, documented total hysterectomy, bilateral ovariectomy, orbilateral salpingectomy, or post-menopause.
  • Female participants of childbearing potential may be enrolled in the study, if theparticipant:
  • Has practiced effective contraception for 1 month prior to study interventionadministration, 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 monthsafter completion of the study vaccination series.

Exclusion

Exclusion Criteria: Medical conditions

  • Any clinical condition that, in the opinion of the investigator, might pose additionalrisk to the participant due to participation in the study or might confound post-studyintervention administration safety assessments (e.g., tattoos overlying either studyintervention administration site).
  • History of any reaction or hypersensitivity likely to be exacerbated by any componentof 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 renalfunctional abnormality, as determined by medical history or physical examination.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based onmedical 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 thefirst dose of study intervention(s) (Day -29 to Day 1), or their planned use duringthe study period.
  • Planned administration/administration of a vaccine not foreseen by the study protocolin the period starting 30 days before first dose and ending 30 days after the lastdose of study intervention administration. However, for HZ/su and mRNA-1273 boostercohort: licensed pneumococcal vaccines and non-replicating vaccines (i.e., inactivatedand subunit vaccines, including inactivated and subunit influenza vaccines, with orwithout adjuvant for seasonal or pandemic flu) may be administered up until 8 daysprior to dose 1 of HZ/su and/or dose 2 of HZ/su and/or at least 14 days after any doseof HZ/su. For Flu D-QIV and mRNA-1273 booster cohort: licensed pneumococcal vaccinesand non-replicating vaccines (i.e., inactivated and subunit vaccines, other thaninfluenza vaccines) may be administered up until 8 days prior to dose 1 of Flu D-QIVand/or at least 30 days after any dose of Flu D-QIV. For time interval between otherroutine vaccines with mRNA-1273 booster dose (administered in the study), localguidelines must be followed. In case emergency mass vaccination for an unforeseen public health threat (e.g., apandemic) is organized by public health authorities outside the routine immunizationprogram, the time period described above can be reduced if necessary for that massvaccination vaccine, provided this vaccine is licensed and used according to its ProductInformation.
  • Administration of long-acting immune-modifying drugs at any time during the studyperiod (e.g., infliximab).
  • Administration of immunoglobulins and/or any blood products or plasma derivativesduring the period starting 3 months before the first dose of study intervention(s) upto 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) ofimmunosuppressants or other immune-modifying drugs during the period starting 3 monthsprior to the first vaccine. For corticosteroids, this will mean more than 14 days intotal of prednisone ≥20 mg/day or equivalent is not allowed. Inhaled, intra-articularand topical steroids are allowed.
  • For HZ/su and mRNA-1273 booster cohort: Previous vaccination against Herpes Zosterwith the exception of receipt of live attenuated HZ vaccine.
  • For Flu D-QIV and mRNA-1273 booster cohort: Administration of a seasonal influenzavaccine 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 treatCOVID-19), at any time during the study period, in which the participant has been or willbe exposed to an investigational or a non-investigational vaccine / product (drug ormedical device). Other exclusions

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

Study Design

Total Participants: 2013
Treatment Group(s): 3
Primary Treatment: mRNA-1273
Phase: 3
Study Start date:
October 07, 2021
Estimated Completion Date:
August 31, 2022

Connect with a study center

  • GSK Investigational Site

    Tempe, Arizona 85283
    United States

    Site Not Available

  • GSK Investigational Site

    Oxnard, California 93030-5841
    United States

    Site Not Available

  • GSK Investigational Site

    San Diego, California 92103-6204
    United States

    Site Not Available

  • GSK Investigational Site

    Atlantis, Florida 33462
    United States

    Site Not Available

  • GSK Investigational Site

    Fort Myers, Florida 33912
    United States

    Site Not Available

  • GSK Investigational Site

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • GSK Investigational Site

    Lake Worth, Florida 33461
    United States

    Site Not Available

  • GSK Investigational Site

    Miami, Florida 33173
    United States

    Site Not Available

  • GSK Investigational Site

    Ocala, Florida 34471
    United States

    Site Not Available

  • GSK Investigational Site

    Orlando, Florida 32801
    United States

    Site Not Available

  • GSK Investigational Site

    Sarasota, Florida 34243-2878
    United States

    Site Not Available

  • GSK Investigational Site

    Atlanta, Georgia 30308
    United States

    Site Not Available

  • GSK Investigational Site

    Columbus, Georgia 31904
    United States

    Site Not Available

  • GSK Investigational Site

    Meridian, Idaho 83642
    United States

    Site Not Available

  • GSK Investigational Site

    El Dorado, Kansas 67042
    United States

    Site Not Available

  • GSK Investigational Site

    Newton, Kansas 67114
    United States

    Site Not Available

  • GSK Investigational Site

    Topeka, Kansas 66606
    United States

    Site Not Available

  • GSK Investigational Site

    Wichita, Kansas 67207
    United States

    Site Not Available

  • GSK Investigational Site

    Lexington, Kentucky 40509
    United States

    Site Not Available

  • GSK Investigational Site

    Biloxi, Mississippi 39531
    United States

    Site Not Available

  • GSK Investigational Site

    Fremont, Nebraska 68025-2592
    United States

    Site Not Available

  • GSK Investigational Site

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • GSK Investigational Site

    Berlin, New Jersey 08009
    United States

    Site Not Available

  • GSK Investigational Site

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • GSK Investigational Site

    Norman, Oklahoma 73072
    United States

    Site Not Available

  • GSK Investigational Site

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • GSK Investigational Site

    Yukon, Oklahoma 73099
    United States

    Site Not Available

  • GSK Investigational Site

    Grants Pass, Oregon 97527
    United States

    Site Not Available

  • GSK Investigational Site

    Anderson, South Carolina 29621
    United States

    Site Not Available

  • GSK Investigational Site

    Columbia, South Carolina 29204
    United States

    Site Not Available

  • GSK Investigational Site

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • GSK Investigational Site

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • GSK Investigational Site

    Beaumont, Texas 77706
    United States

    Site Not Available

  • GSK Investigational Site

    Cedar Park, Texas 78613
    United States

    Site Not Available

  • GSK Investigational Site

    Houston, Texas 77090
    United States

    Site Not Available

  • GSK Investigational Site

    San Antonio, Texas 78229
    United States

    Site Not Available

  • GSK Investigational Site

    Tomball, Texas 77375
    United States

    Site Not Available

  • GSK Investigational Site

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • GSK Investigational Site

    West Jordan, Utah 84088
    United States

    Site Not Available

  • GSK Investigational Site

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • GSK Investigational Site

    Cheney, Washington 99204
    United States

    Site Not Available

  • GSK Investigational Site

    Tacoma, Washington 98405
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.