Evaluation of Pandemic Influenza A (H1N1)Candidate Vaccines

Evaluation of Safety, Tolerability and Immunogenicity of Adjuvanted Candidate Vaccines Against Pandemic Influenza A (H1N1)

This is a prospective phase I study to evaluate the safety, tolerability and immunogenicity of nine adjuvanted candidate vaccines against pandemic influenza A (H1N1) virus.

The candidate vaccines are produced by Butantan institute - Sao Paulo, Brazil

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