Phase
Condition
Chickenpox (Varicella Zoster Infection)
Herpes Simplex Infections
Shingles
Treatment
mRNA-1273
Flu D-QIV
HZ/su
Clinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
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
Connect with a study center
GSK Investigational Site
Tempe, Arizona 85283
United StatesSite Not Available
GSK Investigational Site
Oxnard, California 93030-5841
United StatesSite Not Available
GSK Investigational Site
San Diego, California 92103-6204
United StatesSite Not Available
GSK Investigational Site
Atlantis, Florida 33462
United StatesSite Not Available
GSK Investigational Site
Fort Myers, Florida 33912
United StatesSite Not Available
GSK Investigational Site
Jacksonville, Florida 32256
United StatesSite Not Available
GSK Investigational Site
Lake Worth, Florida 33461
United StatesSite Not Available
GSK Investigational Site
Miami, Florida 33173
United StatesSite Not Available
GSK Investigational Site
Ocala, Florida 34471
United StatesSite Not Available
GSK Investigational Site
Orlando, Florida 32801
United StatesSite Not Available
GSK Investigational Site
Sarasota, Florida 34243-2878
United StatesSite Not Available
GSK Investigational Site
Atlanta, Georgia 30308
United StatesSite Not Available
GSK Investigational Site
Columbus, Georgia 31904
United StatesSite Not Available
GSK Investigational Site
Meridian, Idaho 83642
United StatesSite Not Available
GSK Investigational Site
El Dorado, Kansas 67042
United StatesSite Not Available
GSK Investigational Site
Newton, Kansas 67114
United StatesSite Not Available
GSK Investigational Site
Topeka, Kansas 66606
United StatesSite Not Available
GSK Investigational Site
Wichita, Kansas 67207
United StatesSite Not Available
GSK Investigational Site
Lexington, Kentucky 40509
United StatesSite Not Available
GSK Investigational Site
Biloxi, Mississippi 39531
United StatesSite Not Available
GSK Investigational Site
Fremont, Nebraska 68025-2592
United StatesSite Not Available
GSK Investigational Site
Omaha, Nebraska 68114
United StatesSite Not Available
GSK Investigational Site
Berlin, New Jersey 08009
United StatesSite Not Available
GSK Investigational Site
Albuquerque, New Mexico 87102
United StatesSite Not Available
GSK Investigational Site
Norman, Oklahoma 73072
United StatesSite Not Available
GSK Investigational Site
Oklahoma City, Oklahoma 73112
United StatesSite Not Available
GSK Investigational Site
Yukon, Oklahoma 73099
United StatesSite Not Available
GSK Investigational Site
Grants Pass, Oregon 97527
United StatesSite Not Available
GSK Investigational Site
Anderson, South Carolina 29621
United StatesSite Not Available
GSK Investigational Site
Columbia, South Carolina 29204
United StatesSite Not Available
GSK Investigational Site
Greenville, South Carolina 29615
United StatesSite Not Available
GSK Investigational Site
Memphis, Tennessee 38119
United StatesSite Not Available
GSK Investigational Site
Beaumont, Texas 77706
United StatesSite Not Available
GSK Investigational Site
Cedar Park, Texas 78613
United StatesSite Not Available
GSK Investigational Site
Houston, Texas 77090
United StatesSite Not Available
GSK Investigational Site
San Antonio, Texas 78229
United StatesSite Not Available
GSK Investigational Site
Tomball, Texas 77375
United StatesSite Not Available
GSK Investigational Site
Salt Lake City, Utah 84107
United StatesSite Not Available
GSK Investigational Site
West Jordan, Utah 84088
United StatesSite Not Available
GSK Investigational Site
Norfolk, Virginia 23502
United StatesSite Not Available
GSK Investigational Site
Cheney, Washington 99204
United StatesSite Not Available
GSK Investigational Site
Tacoma, Washington 98405
United StatesSite Not Available
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