Influenza Clinical Trial
Official title:
Evaluation of Safety, Tolerability and Immunogenicity of Adjuvanted Candidate Vaccines Against Pandemic Influenza A (H1N1)
Verified date | February 2013 |
Source | Butantan Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: National Health Surveillance Agency |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 266 |
Est. completion date | March 2011 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 50 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Brazil | Centro de Pesquisa Clínica do Hospital Universitário da USP | Sao Paulo | |
Brazil | Centro de Pesquisa Clinica do Instituto da Criança do hospital das Clinicas da Faculdade de Medicina da USP | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
Butantan Institute | Hospital Universitario da USP, University of Sao Paulo |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay | Volunteers will receive two doses of vaccine,21 days apart. | 21 days after each vaccination | No |
Secondary | Safety and tolerability | Evaluation of local and systemic adverse effects throught the study period | 30 minutes and 72 hours after vaccination | Yes |
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