Phase I clinical study to evaluate the safety and tolerability of Quadrivalent Influenza Vaccine (QIV) delivered intradermally by a high-density micro-array patch (HD MAP), compared to intramuscular Influvac® Tetra injection, in healthy adults aged 18 to 50 years
- Conditions
- respiratory infectionInfluenzaRespiratory - Other respiratory disorders / diseases
- Registration Number
- ACTRN12622001203741
- Lead Sponsor
- Vaxxas Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 150
1)Aged 18 to 50 years (inclusive) at the time of consent;
2)Body mass index (BMI) within the range 18.0 to 32.0 kg/m² (inclusive) at Screening;
3)Being in good health, as determined by satisfactory medical history, physical examination, vital signs, laboratory evaluation and clinical judgment of the Investigator. Participants with stable, chronic underlying illnesses such as psychiatric/psychological disorders, hypertension, diabetes, ischemic heart disease or hypothyroidism (or other conditions as per investigator’s discretion) may be enrolled provided their signs and symptoms are controlled. If on regular prescription medication, the medication dose must have been stable for at least three months prior to Screening;
4)Adequate venous access in left or right arm to allow collection of a number of small-volume blood samples at different time points;
5)Women of childbearing potential must return a negative pregnancy test at Screening (serum) and pre-dose on Day 1 (urine), and must agree to remain sexually abstinent, use medically effective contraception or have a partner who is sterile or same-sex, from Screening through EoS. Post menopausal women can be included, and are defined as those with at least 12 months since their last menstrual period;
6)Non-surgically sterilised, sexually active male participants with a female partner of child-bearing potential must agree to use condoms, together with medically effective contraception for their female partner;
7)Participant is able to communicate effectively with study personnel and is considered likely to be reliable, willing and cooperative in terms of compliance with the protocol requirements;
8)Participant is able and willing to provide written, personally signed, informed consent to participate in the study.
1)Participants who have received a registered or investigational (confirmed active) influenza vaccination within the six months prior to Day 1;
2)Participants who have had laboratory-confirmed influenza infection within the six months prior to Day 1;
3)Participants with birthmarks, tattoos, wounds, scars, moles, blemishes, heavy hair or other skin conditions (such as eczema) at the planned vaccination site that could be expected to obscure the observation of application-site reactions;
4)Participant with known chronic spontaneous urticaria or dermographism;
5)Known predisposition to keloid-scar formation;
6)Known anaphylactic hypersensitivity to haemagglutinin or to any of the vaccine excipients (potassium chloride, potassium phosphate, sodium phosphate, sodium chloride, calcium chloride, magnesium chloride, sulfobutyl-ß-cyclodextrin) and to residues of eggs (ovalbumin, chicken proteins), formaldehyde, cetrimonium bromide, polysorbate 80, gentamicin, sodium citrate, sucrose, tylosine tartrate, or hydrocortisone;
7)Allergy to a previous vaccination at any time in the past;
8)Recent vaccination (within 30 days prior to Day 1) or any planned vaccination up to Day 22 with any non-influenza vaccine. In addition, any planned vaccination with influenza vaccine other than the study vaccines for the duration of the study;
9)Known history of demyelinating disease or Guillain-Barré syndrome;
10)History of granulomatous diseases, including sarcoidosis and granuloma annulare;
11)History of convulsions, epilepsy, other central nervous system diseases, excluding febrile convulsions experienced as a child that are considered resolved;
12)History of clinically significant haematological, gastrointestinal, hepatic, renal, cardiovascular, dermatological, immunological, respiratory, endocrine, oncological, neurological, metabolic, psychiatric disease, that, at the discretion of the Investigator, precludes the participant from the study;
13)Presence of active viral of bacterial infection, with or without fever (tympanic temperature greater than or equal to 38.0 °C), at Day 1 or within 72 hours prior to study vaccination, if determined by the Investigator to be of clinical significance. Participants with a minor illness such as mild diarrhoea or mild upper respiratory infection without fever may be enrolled at the discretion of the Investigator. Enrolment may be deferred for up to two weeks provided participant remains otherwise eligible and the total Screening period does not exceed 28 days;
14)History of any haematological malignancy or active neoplastic disease (excluding non-melanoma skin cancer that was successfully treated). Active is defined as having received treatment within the 5 years prior to Screening;
15)Presence of an active medical condition, defined as a condition under current evaluation or treatment, that is considered clinically significant by the Investigator, or a recent illness that is considered clinically significant by the Investigator;
16)Any condition that, in the opinion of the Investigator, is considered clinically significant or might interfere with the evaluation of the study objectives;
17)Planned surgery requiring a general anaesthetic, or surgery requiring inpatient hospitalisation for at least 24 hours during the entire study period.
18)History of illness and/or infection with Hepatitis B, or Hepatitis C or Human Immunodeficiency Virus (HIV), or a positive test for Hepatitis B surfac
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method