A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline Biologicals' Influenza Vaccine GSK3206641A Administered in Adults 18 to 64 Years of Age and 65 Years of Age and Older

  • STATUS
    Recruiting
  • End date
    Jun 28, 2022
  • participants needed
    840
  • sponsor
    GlaxoSmithKline
Updated on 4 June 2021
tubal ligation
hysterectomy
vaccination
trivalent influenza vaccine
immunomodulators

Summary

Study to evaluate the safety and immunogenicity of H7N9 antigen in combination with full or half doses of AS03 adjuvant system in healthy adults.

Details
Condition Influenza
Treatment Placebo, FLU-Q-PAN H7N9 Formulation 1, FLU-Q-PAN H7N9 Formulation 2, FLU-Q-PAN H7N9 Formulation 3, AS03B, AS03A
Clinical Study IdentifierNCT04789577
SponsorGlaxoSmithKline
Last Modified on4 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Healthy participants as established by medical history and clinical examination before entering into the study
A male or female 18 years of age at the time of first vaccination
Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards and COVID-19 assessment card, return for follow-up visits, or return the diary cards and COVID-19 assessment card in a timely manner using the pre stamped envelope received at the site)
Written or witnessed/thumb printed informed consent obtained from the participant prior to performance of any study specific procedure
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 hysterectomy, bilateral ovariectomy or post-menopause
Female participants of childbearing potential may be enrolled in the study, if the
participant
has practiced adequate contraception for 1 month prior to vaccination, and
has a negative pregnancy test on the day of vaccination, and
has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series

Exclusion Criteria

Current diagnosis or history of autoimmune disorder(s)
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine
Hypersensitivity to latex
Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality that appears uncontrolled, as determined by history or physical examination
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required)
Recurrent history or uncontrolled neurological disorders or seizures
History of Guillain-Barr syndrome
Diagnosed with narcolepsy; or history of narcolepsy in a participant's parent, sibling or child
Diagnosed with cancer, or treatment for cancer within 3 years
Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible
Persons with a history of histologically-confirmed basal cell carcinoma of the skin successfully treated with local excision only are accepted and are eligible, but other histologic types of skin cancer are exclusionary
Women who are disease-free 3 years or more after treatment for breast cancer and receiving long-term prophylaxis (for example, with tamoxifen) are eligible
Documented human immunodeficiency virus-positive participant
Any clinically significant hematological laboratory abnormality
The investigator should use his/her clinical judgement to decide which abnormalities are clinically significant
Bedridden participants
Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study
Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study vaccine/product during the period beginning 30 days before the first dose of study vaccine/product (Day -29 to Day 1), or planned use during the study period
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 vaccine/product or planned administration during the study period
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/product dose. For corticosteroids, this will mean prednisone equivalent 20 mg/day. Inhaled and topical steroids are allowed
Concurrently participating in another clinical study, 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)
Pregnant or lactating female
Female planning to become pregnant or planning to discontinue contraceptive precautions within 2 months after completion of the vaccination series
History of or current chronic alcohol consumption and/or drug abuse
Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study
Any study personnel or immediate dependents, family, or household member
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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