Influenza (Pandemic)
Conditions
Keywords
H7N9
Brief summary
This is a randomized, observer-blinded, placebo-controlled trial in adults 18 to 64 years old. Randomization will be stratified by age (18 to 49 years and 50 to 64 years) and by prior influenza immunization within the past three months. Subjects 18 to 49 years of age will comprise \ 67% of subjects in each treatment group, and the balance will comprise subjects 50 to 64 years. Each subject will receive two identical IM doses of test article 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
Department of Health and Human Services
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 64 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy adult male or female, 18 to 64 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 child-bearing potential must have a negative urine pregnancy test prior to each vaccination, and 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 will be excluded if they meet any of the following criteria: 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. * Acute or chronic illnesses or conditions which may be reasonably predicted to become symptomatic if treatment were withdrawn or interrupted are exclusionary, even if stable. * Note that illnesses or conditions may be exclusionary, even if otherwise stable and clinically minor, due to therapies used to treat them (see
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Safety | Day 0 to Day 384 | Counts (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 42 days post-first injection. In addition, MAEs, SAEs, and SNMCs will be collected for one year. |
| 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
United States
Outcome results
None listed