None listed
Conditions
Interventions
Group A Type of group
Two doses of 1 ug of VAX102 intramuscularly
Group name:Group C Type of group
two doses of placebo intramuscularly or subcutaneously
Sponsors
VaxInnate Corporation,
Eligibility
Age
18 Years to 49 Years
Inclusion criteria
Inclusion criteria: • Adult man or woman, between 18 and 49 years old inclusive. • Able and willing to provide written informed consent to participate. • Healthy, if so determined by your medical history, a brief physical exam and your vital signs. • Willing to receive the unlicensed vaccine (VAX102) or placebo administered as an intramuscular or subcutaneous injection. • Willing to provide multiple blood samples collected per venipuncture. • Willing to notify the study staff of any event related to influenza-like illness, information about the symptoms of the disease, and allow the collection of a pharyngeal (swab) culture sample for laboratory studies. • Women should avoid becoming pregnant • Women of childbearing age must undergo a urine test that must be negative within 24 hours prior to receiving the first vaccine and the booster vaccine. • You must understand the requirements of the study, expressly state your availability for the required study and reside within the study area throughout the study period, and must be able to attend scheduled visits.
Exclusion criteria
Exclusion criteria: • People under 18 years. • People with chronic diseases such as diabetes, liver or kidney disease • Woman who is pregnant, nursing mother or woman who is planning a pregnancy during the month after vaccination. • Person who has had a serious reaction to an influenza vaccine. • Person with a history of anaphylactic reaction to injected vaccines. • Person with a history of drug or chemical abuse during the year prior to the study. • Person who received an influenza vaccine for the current influenza season or those who plan to receive an influenza vaccine while participating in the study. • Person who received any other vaccine during the week prior to enrollment (could delay enrollment). • Person who has had respiratory illness or fever illness within 3 days prior to enrollment (could delay enrollment). • Person currently participating in another research study that involves any study medication (medicines or vaccines).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The number of patients in a dose group as well as the placebo group that, as confirmed, has symptomatic influenza A will be identified using RT-PCR. In general, all collected data will be listed. Categorical variables will be summarized by dose group as frequencies and percentages in each category. Continuous variables will be summarized by dose group such as patient numbers, means, standard deviations, medians, and maximum / minimum values. Measure:Proportion of patients with confirmed presence of influenza A virus Timepoints:At the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:95% internal unilateral confidence intervals will be constructed for the estimated proportions. A unilateral p-value will be calculated for the relative risk test statistics with variance for data not grouped based on the observed data. Measure:Number of patients with confirmed symptomatic influenza A Timepoints:At the end of the study | — |
Countries
Peru
Contacts
Public ContactLuis Miguel Melendez
PPD Peru S.A.C.
Outcome results
None listed