Evaluation of Pandemic Influenza A (H1N1)Candidate Vaccines
Influenza
About this trial
This is an interventional prevention trial for Influenza focused on measuring vaccine, pandemic influenza A, adjuvant, safety
Eligibility Criteria
Inclusion Criteria:
- Health adults of both genders
- Age ≥ 18 ≤ 50 years
- Able to understand every required study procedure
- Female volunteers should agree to take an acceptable contraceptive method Menopause is characterized by absence of menstrual flux for two consective years
- Normal values for pre-stablished laboratory assays
- Accpetance to participate and sign the consent form
Exclusion Criteria:
- Any chronic condition
- Be on immunossupressive or stimulant therapy
- Have egg alergy
- Have past history of alergy to sazonal influenza vaccine
- Have received another inactivated vaccine within the prior 2 weeks or a live vaccine in the past four weeks to his/her participation in the study
- Acute infectious disease during seven days prior vaccination
- Female on breasthfeeding
- Confirmed prior infection by pandemic influenza A
- Participation in another clinical trial in the last 6 months
- Any other condition identified by the principal investigator which is considered not safe for enrollment of the volunteer
Sites / Locations
- Centro de Pesquisa Clinica do Instituto da Criança do hospital das Clinicas da Faculdade de Medicina da USP
- Centro de Pesquisa Clínica do Hospital Universitário da USP
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
pandemic vaccine 1
pandemic vaccine 2
pandemic vaccine 5
pandemic vaccine 6
pandemic vaccine 9
pandemic vaccine 10
pandemic vaccine 11
pandemic vaccine 12
pandemic vaccine 13
placebo group 14
7,5µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3
3,75µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3
7,5µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emulsion
3,75µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emultion
7,5 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion
3,75 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion
7,5µg of A/H1N1 with Al(OH)3
3,75µg of A/H1N1 with Al(OH)3
15µg of A/H1N1 with no adjuvant
placebo