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
NCT ID: NCT05047770
Last Updated: 2023-11-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2013 participants
INTERVENTIONAL
2021-10-07
2022-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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HZ/suSeq Group
Participants randomized to HZ/suSeq Group received 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.
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 was administered 8 weeks after the first dose of HZ/su vaccine.
mRNA-1273
1 booster dose of mRNA-1273 vaccine administered intramuscularly at Day 1 (all groups).
HZ/suCoAd Group
Participants randomized to HZ/suCoAd Group received 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.
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 was administered 8 weeks after the first dose of HZ/su vaccine.
mRNA-1273
1 booster dose of mRNA-1273 vaccine administered intramuscularly at Day 1 (all groups).
FluD-QIVSeq Group
Participants randomized to FluD-QIVSeq Group received one mRNA-1273 booster dose at Day 1, followed by one dose of Flu D-QIV vaccine at Week 2.
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.
mRNA-1273
1 booster dose of mRNA-1273 vaccine administered intramuscularly at Day 1 (all groups).
FluD-QIVCoAd Group
Participants randomized to FluD-QIVCoAd Group received one mRNA-1273 booster dose co-administered with one dose of Flu D-QIV vaccine at Day 1.
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.
mRNA-1273
1 booster dose of mRNA-1273 vaccine administered intramuscularly at Day 1 (all groups).
Interventions
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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 was administered 8 weeks after the first dose of HZ/su vaccine.
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.
mRNA-1273
1 booster dose of mRNA-1273 vaccine administered intramuscularly at Day 1 (all groups).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Tempe, Arizona, United States
GSK Investigational Site
Oxnard, California, United States
GSK Investigational Site
San Diego, California, United States
GSK Investigational Site
San Diego, California, United States
GSK Investigational Site
Atlantis, Florida, United States
GSK Investigational Site
Fort Myers, Florida, United States
GSK Investigational Site
Jacksonville, Florida, United States
GSK Investigational Site
Lake Worth, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Ocala, Florida, United States
GSK Investigational Site
Orlando, Florida, United States
GSK Investigational Site
Sarasota, Florida, United States
GSK Investigational Site
Atlanta, Georgia, United States
GSK Investigational Site
Columbus, Georgia, United States
GSK Investigational Site
Meridian, Idaho, United States
GSK Investigational Site
El Dorado, Kansas, United States
GSK Investigational Site
Newton, Kansas, United States
GSK Investigational Site
Topeka, Kansas, United States
GSK Investigational Site
Wichita, Kansas, United States
GSK Investigational Site
Lexington, Kentucky, United States
GSK Investigational Site
Biloxi, Mississippi, United States
GSK Investigational Site
Fremont, Nebraska, United States
GSK Investigational Site
Omaha, Nebraska, United States
GSK Investigational Site
Berlin, New Jersey, United States
GSK Investigational Site
Albuquerque, New Mexico, United States
GSK Investigational Site
Columbus, Ohio, United States
GSK Investigational Site
Norman, Oklahoma, United States
GSK Investigational Site
Oklahoma City, Oklahoma, United States
GSK Investigational Site
Yukon, Oklahoma, United States
GSK Investigational Site
Grants Pass, Oregon, United States
GSK Investigational Site
Anderson, South Carolina, United States
GSK Investigational Site
Columbia, South Carolina, United States
GSK Investigational Site
Greenville, South Carolina, United States
GSK Investigational Site
Memphis, Tennessee, United States
GSK Investigational Site
Beaumont, Texas, United States
GSK Investigational Site
Cedar Park, Texas, United States
GSK Investigational Site
Houston, Texas, United States
GSK Investigational Site
San Antonio, Texas, United States
GSK Investigational Site
Tomball, Texas, United States
GSK Investigational Site
Salt Lake City, Utah, United States
GSK Investigational Site
West Jordan, Utah, United States
GSK Investigational Site
Norfolk, Virginia, United States
GSK Investigational Site
Cheney, Washington, United States
GSK Investigational Site
Tacoma, Washington, United States
Countries
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References
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Naficy A, Kuxhausen A, Seifert H, Hastie A, Leav B, Miller J, Anteyi K, Mwakingwe-Omari A. No immunological interference or concerns about safety when seasonal quadrivalent influenza vaccine is co-administered with a COVID-19 mRNA-1273 booster vaccine in adults: A randomized trial. Hum Vaccin Immunother. 2024 Dec 31;20(1):2327736. doi: 10.1080/21645515.2024.2327736. Epub 2024 Mar 21.
de Oliveira Gomes J, Gagliardi AM, Andriolo BN, Torloni MR, Andriolo RB, Puga MEDS, Canteiro Cruz E. Vaccines for preventing herpes zoster in older adults. Cochrane Database Syst Rev. 2023 Oct 2;10(10):CD008858. doi: 10.1002/14651858.CD008858.pub5.
Naficy A, Kuxhausen A, Pirrotta P, Leav B, Miller J, Anteyi K, Danier J, Breuer T, Mwakingwe-Omari A. No Immunological Interference or Safety Concerns When Adjuvanted Recombinant Zoster Vaccine Is Coadministered With a Coronavirus Disease 2019 mRNA-1273 Booster Vaccine in Adults Aged 50 Years and Older: A Randomized Trial. Clin Infect Dis. 2023 Nov 11;77(9):1238-1246. doi: 10.1093/cid/ciad361.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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217670
Identifier Type: -
Identifier Source: org_study_id
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