Avian Influenza
Conditions
Keywords
H7N9
Brief summary
This is a randomized, observer-blinded, placebo-controlled trial in adults ≥18 years old. Randomization will be stratified by age (18 to 49 years and ≥50 years) and by prior influenza immunization within the past three months. Proportions of subjects in the various strata will not be pre-specified; rather, the goal will be to achieve an approximately equal distribution of subjects with these characteristics across the various treatment groups. Treatments will comprise two identical IM doses at a 21-day interval (Day 0 and Day 21), in alternate deltoids. For each subject, study follow-up will span approximately 385 days total, or approximately 13 months from the first dose.
Interventions
Sponsors
Novavax
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Subjects must meet all of the following to be eligible for participation in the study: 1. Healthy adult male or female, ≥18 years of age, 2. Willing and able to give informed consent prior to study enrollment, 3. Able to comply with study requirements, and 4. Women of childbearing potential must have a negative urine pregnancy test prior to each vaccination, will be advised through the Informed Consent process to avoid becoming pregnant over the duration of the study, and must assert that they will employ an effective form of birth control for the duration of the study. Acceptable forms of birth control are: credible history of continuous abstinence from heterosexual activity or prior surgical sterilization, hormonal contraceptives (oral, injectable, implant, patch, ring), barrier contraceptives (condom or diaphragm), and intrauterine device (IUD). Women with an adequately documented history of surgical sterility, or ≥50 years of age and without menses for ≥ 1 year are exempt from urine pregnancy testing.
Exclusion criteria
Subjects meeting any of the following criteria are not eligible for participation in the study. 1. Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care. * Asymptomatic conditions or findings (e.g., mild hypertension, dyslipidemia) that are not associated with evidence of end-organ damage are not exclusionary provided that they are being appropriately managed and are clinically stable (i.e., unlikely to result in symptomatic illness within the time-course of this study) in the opinion of the investigator. * Note that illnesses or conditions may be exclusionary, even if otherwise stable, due to therapies used to treat them (see
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Safety | Day 0 to Day 384 | Number (and percentages) of subjects with solicited local and systemic AEs over the seven days post-injection and all adverse events, solicited and unsolicited, including adverse changes in clinical laboratory parameters, over 35 days post-first injection. Significant New Medical Conditions, Medically Attended Events and Serious Adverse Events will be collected for one year post-second injection. |
| Immunogenicity as assessed by hemagglutination-inhibiting (HAI) antibody titers against the vaccine-homologous A/Anhui/1/13 (H7N9) virus. | Day 0 to Day 384 | * Geometric mean titer (GMT) * Geometric mean ratio (GMR) * Seroconversion rate (SCR) * Seroresponse rate (SRR) |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity as assessed by neuraminidase-inhibiting antibodies to N9. | Day 0 to Day 384 |
Countries
Australia
Outcome results
None listed