PHASE 11 STUDY OF THE SAFETY AND IMMUNOGENICITY OF TWO NOVEL H1N1 INFLUENZA VACCINES COMPARED TO PLACEBO AND COMMERCIALLY AVAILABLE TRIVALENT INFLUENZA VACCINE (T1V) IN HEALTHY ADULTS 18-64 YEARS IN LIMA, PER

Not Applicable

• Registration Number: PER-037-12
• Lead Sponsor: VaxInnate Corporation,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-09-12
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. MALE OR FEMALE AGED 18 - 64 YEARS INCLUSIVE
2. GIVE WRITTEN INFORMED CONSENT TO PARTICIPATE
3. HEALTHY, AS DETERMINED BY MEDICAL HISTORY, PHYSICAL EXAMINATION, VITAL SIGNS, AND CLINICAL SAFETY LABORATORY EXAMINATIONS
4. FEMALES SHOULD FULFILL ONE OFTHE FOLLOWING CRITERIA:
• AT LEAST ONE YEAR POST-MENOPAUSAL,
• SURGICALLY STERILE,
• WILL USE INTRAUTERINE DEVICE (IUD), ORAL, IMPLANTABLE, TRANSDERMAL OR INJECTABLE CONTRACEPTIVES OR OTHER FORMS OFRELIABLE CONTRACEPTION, INCLUDING A STERILE SEXUAL PARTNER, FOR 30 DAYS PRIOR TO FIRST VACCINATION AND UNTIL 21 DAYS AFTER VACCINATION
• WILLING TO USE A RELIABLE FORM OF CONTRACEPTION PROVIDED BY THE INVESTIGATOR (E.G., ORAL OR INJECTABLE CONTRACEPTIVES) FOR STUDY DURATION AND UNTIL 21 DAYS AFTER VACCINATION.
5. WOMEN OFCHILDBEARING POTENTIAL MUST HAVE A NEGATIVE URINE PREGNANCY TEST WITHIN 24 HOURS PRECEDING RECEIPT OF VACCINATION
6. COMPREHENSION OF THE STUDY REQUIREMENTS, EXPRESSED AVAILABILITY FOR THE REQUIRED STUDY PERIOD, AND ABILITY TO ATTEND SCHEDULED VISITS
7. WILLING TO RECEIVE THE UNLICENSED (VAX128) VACCINE GIVEN AS AN I.M. INJECTION

Exclusion Criteria

1. PERSONS WHO IN THE OPINION OFTHE INVESTIGATOR, HAVE A PSYCHIATRIC ILLNESS AND/OR MENTAL DISABILITES, A CHRONIC ILLNESS (E.G. LIVER OR KIDNEY DISEASE), OR WHO ARE TAKING A CONCOMITANT THERAPY OR HAVE ANY OTHER CONDITION THAT WOULD INTERFERE WITH THE SUBJECT´S PARTICIPATION IN THE STUDY OR INTERPRETATION OF THE STUDY RESULTS.
2. PERSONS WITH CLINICALLY SIGNIFICANT ABNORMAL LIVER FUNCTION TESTS AT SCREENING, AS DEEMED BY THE INVESTIGATOR.
3. PERSONS WITH POSITIVE FOR HCV ANTIBODIES OR HBSAG.
4. PERSONS HAVING CANCER OR HAVE RECEIVED TREATMENT FOR CANCER WITHIN THREE YEARS AS REPORTED BY THE STUDY SUBJECT (PERSONS WITH A HISTORY OF CANCER WHO ARE DISEASE-FREE WITHOUT TREATMENT FOR THREE YEARS OR MORE ARE ELIGIBLE), EXCLUDING BASAL CELL CARCINOMA (BCC) OR SQUAMOUS CELL CARCINOMA (SCC), WHICH ARE ALLOWED UNLESS LOCATED AT THE VACCINATION SITE.
5. PERSONS WITH IMPAIRED IMMUNE RESPONSIVENESS (OF ANY CAUSE), INCLUDING DIABETES MELLITUS AS DETERMINED BY THE STUDY PHYSICIAN.

Study & Design

• Study Type: Interventional
• Study Design: Not specified