Evaluation of Pandemic Influenza A (H1N1)Candidate Vaccines
- Conditions
- Influenza
- Registration Number
- NCT01111968
- Lead Sponsor
- Butantan Institute
- Brief Summary
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.
- Detailed Description
The candidate vaccines are produced by Butantan institute - Sao Paulo, Brazil
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 266
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay 21 days after each vaccination Volunteers will receive two doses of vaccine,21 days apart.
- Secondary Outcome Measures
Name Time Method Safety and tolerability 30 minutes and 72 hours after vaccination Evaluation of local and systemic adverse effects throught the study period
Related Research Topics
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Trial Locations
- Locations (2)
Centro de Pesquisa Clinica do Instituto da Criança do hospital das Clinicas da Faculdade de Medicina da USP
🇧🇷Sao Paulo, 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, Brazil