PHASE II, RANDOMIZED, PLACEBO CONTROLLED, DOUBLE BLIND, STUDY ABOUT SECURITY, IMMUNOGENICITY AND PRELIMINARY EFFECTIVENESS OF THE VAX102 M2E VACCINE AGAINST THE INFLUENZA IN ADULT AND HEALTHY MILITARY PERUVIAN PEOPLE.
- Conditions
- Pneumonia due to Haemophilus influenzae-J14 Pneumonia due to Haemophilus influenzaeJ14
- Registration Number
- PER-101-09
- Lead Sponsor
- VaxInnate Corporation,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• 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.
• 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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method